Hypertension
Conditions
Brief summary
To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pre ssure.
Interventions
DRUGAmlodipine 5 mg
Amlodipine 5 mg once daily for two weeks
DRUGPlacebo
Placebo to Telmisartan and Amlodipine once daily for eight weeks
DRUGTelmisartan 20 mg
Telmisartan 20 mg once daily for eight weeks
Telmisartan 40 mg once daily for eight weeks
DRUGAmlodipine 10 mg
Amlodipine 10 mg once daily for six weeks
Telmisartan 80 mg once daily for eight weeks
Amlodipine 2.5 mg once daily for eight weeks
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: Male and female patients \>=18 years of age with Stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure \>=95 and \<=119 mmHg Main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | Up to 8 weeks (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. |
| Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | Up to 8 weeks (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. |
| Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | Up to 8 weeks (LOCF) | Observed results |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect) | Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF)) | Observed results |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Observed results |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | End-of-study visit (LOCF) | Observed results |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. |
| Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Observed results |
| Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. |
| Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | Up to 8 weeks (LOCF) | Observed results |
| Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) | Up to 8 weeks (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Seated Trough Pulse Rate | End-of-study visit (LOCF) | Observed results for all patients - key combination therapies |
| Change From Baseline in Standing Trough Cuff Mean DBP | Up to 8 weeks (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. |
| Change From Baseline in Standing Trough Cuff Mean SBP | Up to 8 weeks (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate. |
| Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | 8 weeks | Clinical relevant abnormalities for laboratory parameters and Electrocardiogram (ECG). New abnormal findings or worsening of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations). |
| Change From Baseline in Seated Trough Cuff Mean SBP | Up to 8 weeks (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate. |
| Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate. |
| Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate. |
| Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | Baseline to end-of-study (up to 8 weeks) visit (LOCF) | Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate. |
| DBP Control | End-of-study (up to 8 weeks) visit (LOCF) | DBP control is defined as DBP \< 90 mmHg - key combination therapies |
| DBP Response | End-of-study (up to 8 weeks) visit (LOCF) | DBP response is defined as DBP \< 90 mmHg or a reduction of DBP of \>= 10 mmHg - key combination therapies |
| SBP Response | End-of-study (up to 8 weeks) visit (LOCF) | SBP Response is defined as SBP \< 140 mmHg or a reduction of SBP of \>= 10 mmHg - key combination therapies |
| BP Normality | End-of-study (up to 8 weeks) visit (LOCF) | No: Mean seated SBP \>=140 and/or mean seated DBP \>=90 mmHg at trough High normal: mean seated SBP \>=130 and \<140 mmHg and mean seated DBP \>=85 and \<90 mmHg at trough Normal: mean seated SBP \>=120 and \<130 mmHg and mean seated DBP \>=80 and \<85 mmHg at trough Optimal: mean seated SBP \< 120 mmHg and mean seated DBP \<80 mmHg at trough \- key combination therapies |
| Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | End-of-study (up to 8 weeks) visit (LOCF) | Observed results - key combination therapies |
| Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | End-of-study (up to 8 weeks) visit (LOCF) | Observed results - key combination therapies |
| Change From Baseline in ABPM 24-hour Mean DBP | End-of-study (up to 8 weeks) visit (LOCF) | Observed results - key combination therapies |
| Change From Baseline in ABPM 24-hour Mean SBP | End-of-study (up to 8 weeks) visit (LOCF) | Observed results - key combination therapies |
| Orthostatic Change in Trough Cuff Mean DBP | Week 8 | Calculated as seated minus standing for all patients - key combination therapies |
| Orthostatic Change in Trough Cuff Mean SBP | Week 8 | Calculated as seated minus standing for all patients - key combination therapies |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Baseline to nominal week over the trial | Observed results for key combination therapies |
| Change From Baseline in Seated Trough Cuff DBP | Nominal week over the trial | Observed results for mod-sev patients - key combination therapies |
| BP Control | End-of-study (up to 8 weeks) visit (LOCF) | Percentage of responders (SBP\<140 mmHg and DBP\<90 mmHg) for all patients - key combination therapies |
Countries
Argentina, Brazil, Mexico, South Africa, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo (Pl) placebo tablet plus encapsulated placebo tablet, QD in morning | 46 |
| Telmisartan 20 mg (T20) Telmisartan 20mg tablet, QD in morning | 42 |
| Telmisartan 40 mg (T40) Telmisartan 40mg tablet, QD in morning | 130 |
| Telmisartan 80 mg (T80) Telmisartan 80mg tablet, QD in morning | 135 |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) T20mg tab plus encapsulated A2.5mg capsule, QD in morning | 44 |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) T20mg tab plus encapsulated A5mg capsule, QD in morning | 46 |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) T20mg tab plus 2 encapsulated A5mg capsule, QD in morning | 44 |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) T40mg tab plus encapsulated A2.5mg capsule, QD in morning | 47 |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) T40mg tab plus encapsulated A5mg capsule, QD in morning | 143 |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning | 129 |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) T80mg tab plus encapsulated A2.5mg capsule, QD in morning | 48 |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) T80mg tab plus encapsulated A5mg capsule, QD in morning | 146 |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) T80mg tab plus 2 encapsulated A5mg capsule, QD in morning | 142 |
| Amlodipine 2.5 mg (A2.5) encapsulated Amlodipine 2.5 mg capsule, QD in morning | 50 |
| Amlodipine 5 mg (A5) encapsulated Amlodipine 5 mg capsule, QD in morning | 140 |
| Amlodipine 10 mg (A10) 2 encapsulated Amlodipine 5 mg capsule, QD in morning | 129 |
| Total | 1,461 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 2 | 4 | 1 | 0 | 1 | 0 | 1 | 6 | 0 | 5 | 8 | 2 | 3 | 3 |
| Overall Study | Lack of Efficacy | 2 | 1 | 1 | 6 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 3 | 0 | 1 | 0 | 1 | 2 | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 2 | 0 | 1 | 2 | 0 | 1 | 1 | 3 |
| Overall Study | Randomised in error; pregnancy; moving | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 2 | 1 | 1 | 1 | 2 | 0 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 1 | 1 | 1 | 2 | 2 | 0 | 1 | 4 | 1 | 1 | 2 | 2 | 1 | 5 |
Baseline characteristics
| Characteristic | Placebo (Pl) | Telmisartan 20 mg (T20) | Telmisartan 40 mg (T40) | Telmisartan 80 mg (T80) | Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Amlodipine 2.5 mg (A2.5) | Amlodipine 5 mg (A5) | Amlodipine 10 mg (A10) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 52.5 Years STANDARD_DEVIATION 12.3 | 53.6 Years STANDARD_DEVIATION 10.4 | 52 Years STANDARD_DEVIATION 11 | 53.1 Years STANDARD_DEVIATION 11.3 | 54 Years STANDARD_DEVIATION 10.8 | 54.4 Years STANDARD_DEVIATION 10.2 | 51 Years STANDARD_DEVIATION 11.2 | 50.7 Years STANDARD_DEVIATION 10.2 | 52.3 Years STANDARD_DEVIATION 11.9 | 53.3 Years STANDARD_DEVIATION 11.3 | 54.8 Years STANDARD_DEVIATION 9.7 | 52.7 Years STANDARD_DEVIATION 11.9 | 53.9 Years STANDARD_DEVIATION 11.6 | 55.3 Years STANDARD_DEVIATION 10.4 | 53.1 Years STANDARD_DEVIATION 10.6 | 53.4 Years STANDARD_DEVIATION 10.7 | 53.1 Years STANDARD_DEVIATION 11.1 |
| Sex: Female, Male Female | 17 Participants | 16 Participants | 64 Participants | 75 Participants | 18 Participants | 25 Participants | 18 Participants | 21 Participants | 72 Participants | 67 Participants | 26 Participants | 72 Participants | 78 Participants | 23 Participants | 68 Participants | 64 Participants | 724 Participants |
| Sex: Female, Male Male | 29 Participants | 26 Participants | 66 Participants | 60 Participants | 26 Participants | 21 Participants | 26 Participants | 26 Participants | 71 Participants | 62 Participants | 22 Participants | 74 Participants | 64 Participants | 27 Participants | 72 Participants | 65 Participants | 737 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / — | 5 / — | 4 / — | 5 / — | 6 / — | 13 / — | 3 / — | 9 / — | 13 / — | 5 / — | 1 / — | 10 / — | 23 / — | 2 / — | 10 / — | 29 / — |
| serious Total, serious adverse events | 0 / 46 | 0 / 42 | 0 / 44 | 0 / 46 | 0 / 44 | 0 / 130 | 0 / 47 | 0 / 143 | 0 / 129 | 1 / 135 | 2 / 48 | 2 / 146 | 0 / 142 | 1 / 50 | 1 / 140 | 0 / 129 |
Outcome results
Primary
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) | -12.2 mmHg | Standard Error 0.5 |
| Telmisartan 20 mg (T20) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) | -15.3 mmHg | Standard Error 0.6 |
| Telmisartan 40 mg (T40) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) | -16.2 mmHg | Standard Error 0.4 |
| Telmisartan 80 mg (T80) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) | -19.3 mmHg | Standard Error 0.4 |
Primary
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | -12.5 mmHg | Standard Error 0.5 |
| Telmisartan 20 mg (T20) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | -16.8 mmHg | Standard Error 0.6 |
| Telmisartan 40 mg (T40) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | -16.6 mmHg | Standard Error 0.4 |
| Telmisartan 80 mg (T80) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | -17.2 mmHg | Standard Error 0.4 |
Primary
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -6.2 mmHg | Standard Error 1.2 |
| Telmisartan 20 mg (T20) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -13.8 mmHg | Standard Error 1.3 |
| Telmisartan 40 mg (T40) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -13.4 mmHg | Standard Error 0.7 |
| Telmisartan 80 mg (T80) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -14 mmHg | Standard Error 0.7 |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -18.3 mmHg | Standard Error 1.2 |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -15.9 mmHg | Standard Error 1.2 |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -19.3 mmHg | Standard Error 1.3 |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -16.9 mmHg | Standard Error 1.2 |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -16.5 mmHg | Standard Error 0.7 |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -20.2 mmHg | Standard Error 0.7 |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -15.7 mmHg | Standard Error 1.2 |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -18.2 mmHg | Standard Error 0.7 |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -20.1 mmHg | Standard Error 0.7 |
| Amlodipine 2.5 mg (A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -10.6 mmHg | Standard Error 1.2 |
| Amlodipine 5 mg (A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -13.4 mmHg | Standard Error 0.7 |
| Amlodipine 10 mg (A10) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -17.11 mmHg | Standard Error 0.7 |
Primary
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC), excluding patients treated with placebo
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -13.8 mmHg | Standard Error 1.2 |
| Telmisartan 20 mg (T20) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -13.4 mmHg | Standard Error 0.7 |
| Telmisartan 40 mg (T40) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -14 mmHg | Standard Error 0.7 |
| Telmisartan 80 mg (T80) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -18.3 mmHg | Standard Error 1.2 |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -15.9 mmHg | Standard Error 1.2 |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -19.3 mmHg | Standard Error 1.3 |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -16.9 mmHg | Standard Error 1.2 |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -16.5 mmHg | Standard Error 0.7 |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -20.2 mmHg | Standard Error 0.7 |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -15.7 mmHg | Standard Error 1.2 |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -18.2 mmHg | Standard Error 0.7 |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -20.1 mmHg | Standard Error 0.7 |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -10.6 mmHg | Standard Error 1.2 |
| Amlodipine 2.5 mg (A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -13.4 mmHg | Standard Error 0.7 |
| Amlodipine 5 mg (A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -17.1 mmHg | Standard Error 0.7 |
Primary
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)
Observed results
Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | -12.3 mmHg | Standard Deviation 9.7 |
| Telmisartan 20 mg (T20) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | -14.9 mmHg | Standard Deviation 8.8 |
| Telmisartan 40 mg (T40) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | -15.6 mmHg | Standard Deviation 8.1 |
| Telmisartan 80 mg (T80) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | -18.6 mmHg | Standard Deviation 7.7 |
Primary
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
Observed results
Time frame: End-of-study visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -5.9 mmHg | Standard Deviation 9.4 |
| Telmisartan 20 mg (T20) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -13.2 mmHg | Standard Deviation 9 |
| Telmisartan 40 mg (T40) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -13.1 mmHg | Standard Deviation 10.1 |
| Telmisartan 80 mg (T80) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -13.6 mmHg | Standard Deviation 8.7 |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -18 mmHg | Standard Deviation 7.8 |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -15.7 mmHg | Standard Deviation 6.5 |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -18.7 mmHg | Standard Deviation 7 |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -16.2 mmHg | Standard Deviation 8.2 |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -16 mmHg | Standard Deviation 7.6 |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -19.6 mmHg | Standard Deviation 7.9 |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -15.3 mmHg | Standard Deviation 7.5 |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -17.8 mmHg | Standard Deviation 8.5 |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -19.6 mmHg | Standard Deviation 7.9 |
| Amlodipine 2.5 mg (A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -10.4 mmHg | Standard Deviation 9.9 |
| Amlodipine 5 mg (A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -13 mmHg | Standard Deviation 7.9 |
| Amlodipine 10 mg (A10) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -16.5 mmHg | Standard Deviation 7.1 |
Primary
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect)
Observed results
Time frame: Baseline to end-of-study (up to 8 weeks) visit (Last Observation Carried Forward (LOCF))
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect) | -13 mmHg | Standard Deviation 8.8 |
| Telmisartan 20 mg (T20) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect) | -16.4 mmHg | Standard Deviation 7.8 |
| Telmisartan 40 mg (T40) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect) | -16.2 mmHg | Standard Deviation 8.9 |
| Telmisartan 80 mg (T80) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Diastolic Blood Pressure (DBP) (Observed Telmisartan Effect) | -16.9 mmHg | Standard Deviation 8.6 |
Primary
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Time frame: Up to 8 weeks (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) | -12.5 mmHg | Standard Error 0.5 |
| Telmisartan 20 mg (T20) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) | -16.4 mmHg | Standard Error 0.7 |
| Telmisartan 40 mg (T40) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) | -16.7 mmHg | Standard Error 0.5 |
| Telmisartan 80 mg (T80) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Amlodipine Effects) | -19.7 mmHg | Standard Error 0.5 |
Primary
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | -12.7 mmHg | Standard Error 0.5 |
| Telmisartan 20 mg (T20) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | -17.3 mmHg | Standard Error 0.7 |
| Telmisartan 40 mg (T40) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | -17.3 mmHg | Standard Error 0.5 |
| Telmisartan 80 mg (T80) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Telmisartan Effects) | -18 mmHg | Standard Error 0.5 |
Primary
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Time frame: Up to 8 weeks (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -5.8 mmHg | Standard Error 1.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -14.4 mmHg | Standard Error 1.4 |
| Telmisartan 40 mg (T40) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -14.2 mmHg | Standard Error 0.8 |
| Telmisartan 80 mg (T80) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -14.1 mmHg | Standard Error 0.9 |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -18.9 mmHg | Standard Error 1.4 |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -15.9 mmHg | Standard Error 1.4 |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -19.7 mmHg | Standard Error 1.6 |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -18.8 mmHg | Standard Error 1.5 |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -17.2 mmHg | Standard Error 0.8 |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -20.1 mmHg | Standard Error 0.8 |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -16.6 mmHg | Standard Error 1.4 |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -19.1 mmHg | Standard Error 0.8 |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -21 mmHg | Standard Error 0.8 |
| Amlodipine 2.5 mg (A2.5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -11.7 mmHg | Standard Error 1.4 |
| Amlodipine 5 mg (A5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -13.3 mmHg | Standard Error 0.8 |
| Amlodipine 10 mg (A10) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects) | -17.6 mmHg | Standard Error 0.9 |
Primary
Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Time frame: Up to 8 weeks (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as moderate or severe hypertension at baseline (FAS-TC-MS), excluding patients treated with placebo
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -14.5 mmHg | Standard Error 1.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -14.2 mmHg | Standard Error 0.8 |
| Telmisartan 40 mg (T40) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -14.1 mmHg | Standard Error 0.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -18.9 mmHg | Standard Error 1.4 |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -15.9 mmHg | Standard Error 1.4 |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -19.7 mmHg | Standard Error 1.5 |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -18.8 mmHg | Standard Error 1.5 |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -17.2 mmHg | Standard Error 0.8 |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -20.1 mmHg | Standard Error 0.8 |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -16.6 mmHg | Standard Error 1.4 |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -19.1 mmHg | Standard Error 0.8 |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -21 mmHg | Standard Error 0.8 |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -11.7 mmHg | Standard Error 1.3 |
| Amlodipine 2.5 mg (A2.5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -13.3 mmHg | Standard Error 0.8 |
| Amlodipine 5 mg (A5) | Change From Baseline in Seated Trough Cuff Mean DBP (Adjusted Treatment Effects, Excluding Pl) | -17.6 mmHg | Standard Error 0.9 |
Primary
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects)
Observed results
Time frame: Up to 8 weeks (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | -12.7 mmHg | Standard Deviation 10.1 |
| Telmisartan 20 mg (T20) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | -16 mmHg | Standard Deviation 8.4 |
| Telmisartan 40 mg (T40) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | -16.3 mmHg | Standard Deviation 8.3 |
| Telmisartan 80 mg (T80) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Amlodipine Effects) | -19.2 mmHg | Standard Deviation 7.8 |
Primary
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect)
Observed results
Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect) | -13.1 mmHg | Standard Deviation 9 |
| Telmisartan 20 mg (T20) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect) | -16.8 mmHg | Standard Deviation 8 |
| Telmisartan 40 mg (T40) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect) | -16.9 mmHg | Standard Deviation 8.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Telmisartan Effect) | -17.7 mmHg | Standard Deviation 8.8 |
Primary
Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects)
Observed results
Time frame: Up to 8 weeks (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -5.5 mmHg | Standard Deviation 10.1 |
| Telmisartan 20 mg (T20) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -13.9 mmHg | Standard Deviation 9.4 |
| Telmisartan 40 mg (T40) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -13.8 mmHg | Standard Deviation 10.2 |
| Telmisartan 80 mg (T80) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -13.9 mmHg | Standard Deviation 9.2 |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -18.4 mmHg | Standard Deviation 7.9 |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -15.8 mmHg | Standard Deviation 6.4 |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -19.5 mmHg | Standard Deviation 7.2 |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -18.7 mmHg | Standard Deviation 7.9 |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -16.8 mmHg | Standard Deviation 7.5 |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -19.6 mmHg | Standard Deviation 8.3 |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -16.3 mmHg | Standard Deviation 7.7 |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -18.8 mmHg | Standard Deviation 9 |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -20.4 mmHg | Standard Deviation 7.3 |
| Amlodipine 2.5 mg (A2.5) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -11.4 mmHg | Standard Deviation 8.3 |
| Amlodipine 5 mg (A5) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -13.1 mmHg | Standard Deviation 8.1 |
| Amlodipine 10 mg (A10) | Change From Baseline in Seated Trough Cuff Mean DBP (Observed Treatment Effects) | -17.1 mmHg | Standard Deviation 7.6 |
Secondary
BP Normality
No: Mean seated SBP \>=140 and/or mean seated DBP \>=90 mmHg at trough High normal: mean seated SBP \>=130 and \<140 mmHg and mean seated DBP \>=85 and \<90 mmHg at trough Normal: mean seated SBP \>=120 and \<130 mmHg and mean seated DBP \>=80 and \<85 mmHg at trough Optimal: mean seated SBP \< 120 mmHg and mean seated DBP \<80 mmHg at trough \- key combination therapies
Time frame: Up to 8 weeks (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic and Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 0 mg (T0) | BP Normality | No (SBP>=140 and/or DBP>=90) | 46.3 percentage of participants |
| Telmisartan 0 mg (T0) | BP Normality | Normal (130>SBP>=120 and 85>DBP>=80) | 18.5 percentage of participants |
| Telmisartan 0 mg (T0) | BP Normality | High Normal (140>SBP>=130 and 90>DBP>=85) | 25.9 percentage of participants |
| Telmisartan 0 mg (T0) | BP Normality | Optimal (SBP<120 and DBP<80) | 9.3 percentage of participants |
| Telmisartan 20 mg (T20) | BP Normality | High Normal (140>SBP>=130 and 90>DBP>=85) | 29.2 percentage of participants |
| Telmisartan 20 mg (T20) | BP Normality | No (SBP>=140 and/or DBP>=90) | 29.2 percentage of participants |
| Telmisartan 20 mg (T20) | BP Normality | Optimal (SBP<120 and DBP<80) | 11.5 percentage of participants |
| Telmisartan 20 mg (T20) | BP Normality | Normal (130>SBP>=120 and 85>DBP>=80) | 30.2 percentage of participants |
| Telmisartan 40 mg (T40) | BP Normality | High Normal (140>SBP>=130 and 90>DBP>=85) | 26.4 percentage of participants |
| Telmisartan 40 mg (T40) | BP Normality | No (SBP>=140 and/or DBP>=90) | 41.5 percentage of participants |
| Telmisartan 40 mg (T40) | BP Normality | Normal (130>SBP>=120 and 85>DBP>=80) | 21.7 percentage of participants |
| Telmisartan 40 mg (T40) | BP Normality | Optimal (SBP<120 and DBP<80) | 10.4 percentage of participants |
| Telmisartan 80 mg (T80) | BP Normality | Optimal (SBP<120 and DBP<80) | 9 percentage of participants |
| Telmisartan 80 mg (T80) | BP Normality | Normal (130>SBP>=120 and 85>DBP>=80) | 41 percentage of participants |
| Telmisartan 80 mg (T80) | BP Normality | High Normal (140>SBP>=130 and 90>DBP>=85) | 27 percentage of participants |
| Telmisartan 80 mg (T80) | BP Normality | No (SBP>=140 and/or DBP>=90) | 23 percentage of participants |
Secondary
BP Normality
No: Mean seated SBP \>=140 and/or mean seated DBP \>=90 mmHg at trough High normal: mean seated SBP \>=130 and \<140 mmHg and mean seated DBP \>=85 and \<90 mmHg at trough Normal: mean seated SBP \>=120 and \<130 mmHg and mean seated DBP \>=80 and \<85 mmHg at trough Optimal: mean seated SBP \< 120 mmHg and mean seated DBP \<80 mmHg at trough \- key combination therapies
Time frame: End-of-study (up to 8 weeks) visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic and Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 0 mg (T0) | BP Normality | No (SBP>=140 and/or DBP>=90) | 41.1 percentage of participants |
| Telmisartan 0 mg (T0) | BP Normality | High Normal (140>SBP>=130 and 90>DBP>=85) | 28.4 percentage of participants |
| Telmisartan 0 mg (T0) | BP Normality | Normal (130>SBP>=120 and 85>DBP>=80) | 21.3 percentage of participants |
| Telmisartan 0 mg (T0) | BP Normality | Optimal (SBP<120 and DBP<80) | 9.2 percentage of participants |
| Telmisartan 20 mg (T20) | BP Normality | High Normal (140>SBP>=130 and 90>DBP>=85) | 30.1 percentage of participants |
| Telmisartan 20 mg (T20) | BP Normality | Normal (130>SBP>=120 and 85>DBP>=80) | 32.5 percentage of participants |
| Telmisartan 20 mg (T20) | BP Normality | Optimal (SBP<120 and DBP<80) | 13 percentage of participants |
| Telmisartan 20 mg (T20) | BP Normality | No (SBP>=140 and/or DBP>=90) | 24.4 percentage of participants |
| Telmisartan 40 mg (T40) | BP Normality | Normal (130>SBP>=120 and 85>DBP>=80) | 25.9 percentage of participants |
| Telmisartan 40 mg (T40) | BP Normality | High Normal (140>SBP>=130 and 90>DBP>=85) | 30.1 percentage of participants |
| Telmisartan 40 mg (T40) | BP Normality | Optimal (SBP<120 and DBP<80) | 9.8 percentage of participants |
| Telmisartan 40 mg (T40) | BP Normality | No (SBP>=140 and/or DBP>=90) | 34.3 percentage of participants |
| Telmisartan 80 mg (T80) | BP Normality | Optimal (SBP<120 and DBP<80) | 14.7 percentage of participants |
| Telmisartan 80 mg (T80) | BP Normality | High Normal (140>SBP>=130 and 90>DBP>=85) | 22.1 percentage of participants |
| Telmisartan 80 mg (T80) | BP Normality | No (SBP>=140 and/or DBP>=90) | 23.5 percentage of participants |
| Telmisartan 80 mg (T80) | BP Normality | Normal (130>SBP>=120 and 85>DBP>=80) | 39.7 percentage of participants |
Secondary
Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP)
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.
Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -2.5 mmHg | Standard Error 1.8 |
| Telmisartan 20 mg (T20) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -15.1 mmHg | Standard Error 1.9 |
| Telmisartan 40 mg (T40) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -14.6 mmHg | Standard Error 1.1 |
| Telmisartan 80 mg (T80) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -14.3 mmHg | Standard Error 1.1 |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -18.8 mmHg | Standard Error 1.9 |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -21 mmHg | Standard Error 1.9 |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -24.4 mmHg | Standard Error 2 |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -21.9 mmHg | Standard Error 1.8 |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -21.8 mmHg | Standard Error 1.1 |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -24.7 mmHg | Standard Error 1.1 |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -17.4 mmHg | Standard Error 1.8 |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -22.1 mmHg | Standard Error 1 |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -26.4 mmHg | Standard Error 1.1 |
| Amlodipine 2.5 mg (A2.5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -11.4 mmHg | Standard Error 1.8 |
| Amlodipine 5 mg (A5) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -15.4 mmHg | Standard Error 1.1 |
| Amlodipine 10 mg (A10) | Change From Baseline at 8 Weeks in Seated Trough Cuff Mean Systolic Blood Pressure (SBP) | -20.7 mmHg | Standard Error 1.1 |
Secondary
Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -4.9 mmHg | Standard Error 1.2 |
| Telmisartan 20 mg (T20) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -10.4 mmHg | Standard Error 1.3 |
| Telmisartan 40 mg (T40) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -10 mmHg | Standard Error 0.8 |
| Telmisartan 80 mg (T80) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -11.1 mmHg | Standard Error 0.8 |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -14.9 mmHg | Standard Error 1.3 |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -13.1 mmHg | Standard Error 1.3 |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -16.9 mmHg | Standard Error 1.3 |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -15.8 mmHg | Standard Error 1.2 |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -13.6 mmHg | Standard Error 0.7 |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -18.4 mmHg | Standard Error 0.8 |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -13.4 mmHg | Standard Error 1.2 |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -16.2 mmHg | Standard Error 0.7 |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -19 mmHg | Standard Error 0.7 |
| Amlodipine 2.5 mg (A2.5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -8.1 mmHg | Standard Error 1.2 |
| Amlodipine 5 mg (A5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -11.3 mmHg | Standard Error 0.7 |
| Amlodipine 10 mg (A10) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean DBP | -14.6 mmHg | Standard Error 0.8 |
Secondary
Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.
Time frame: Baseline to end-of-study (up to 8 weeks) visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -0.5 mmHg | Standard Error 1.9 |
| Telmisartan 20 mg (T20) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -13.2 mmHg | Standard Error 2 |
| Telmisartan 40 mg (T40) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -13.2 mmHg | Standard Error 1.1 |
| Telmisartan 80 mg (T80) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -12.9 mmHg | Standard Error 1.1 |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -17.4 mmHg | Standard Error 1.9 |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -18.9 mmHg | Standard Error 1.9 |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -22.3 mmHg | Standard Error 2 |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -20.3 mmHg | Standard Error 1.8 |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -20 mmHg | Standard Error 1.1 |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -22.8 mmHg | Standard Error 1.1 |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -17.4 mmHg | Standard Error 1.9 |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -21.2 mmHg | Standard Error 1.1 |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -24.9 mmHg | Standard Error 1.1 |
| Amlodipine 2.5 mg (A2.5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -9.1 mmHg | Standard Error 1.9 |
| Amlodipine 5 mg (A5) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -14.7 mmHg | Standard Error 1.1 |
| Amlodipine 10 mg (A10) | Change From Baseline at 8 Weeks in Standing Trough Cuff Mean SBP | -19.1 mmHg | Standard Error 1.2 |
Secondary
Change From Baseline in ABPM 24-hour Mean DBP
Observed results - key combination therapies
Time frame: End-of-study (up to 8 weeks) visit (LOCF)
Population: FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM 24-hour Mean DBP | -11 mmHg | Standard Deviation 7.2 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM 24-hour Mean DBP | -13.2 mmHg | Standard Deviation 7.7 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM 24-hour Mean DBP | -12.8 mmHg | Standard Deviation 7.4 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM 24-hour Mean DBP | -14.6 mmHg | Standard Deviation 6.9 |
Secondary
Change From Baseline in ABPM 24-hour Mean DBP
Observed results for mod-sev patients - key combination therapies
Time frame: Up to 8 weeks (LOCF)
Population: FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM 24-hour Mean DBP | -11 mmHg | Standard Deviation 7.7 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM 24-hour Mean DBP | -13.6 mmHg | Standard Deviation 8 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM 24-hour Mean DBP | -13.6 mmHg | Standard Deviation 7.1 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM 24-hour Mean DBP | -15.3 mmHg | Standard Deviation 7 |
Secondary
Change From Baseline in ABPM 24-hour Mean SBP
Observed results for mod-sev patients - key combination therapies
Time frame: Up to 8 weeks (LOCF)
Population: FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM 24-hour Mean SBP | -16.7 mmHg | Standard Deviation 11.3 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM 24-hour Mean SBP | -20.8 mmHg | Standard Deviation 14.1 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM 24-hour Mean SBP | -20.9 mmHg | Standard Deviation 11 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM 24-hour Mean SBP | -22.7 mmHg | Standard Deviation 9.9 |
Secondary
Change From Baseline in ABPM 24-hour Mean SBP
Observed results - key combination therapies
Time frame: End-of-study (up to 8 weeks) visit (LOCF)
Population: FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM 24-hour Mean SBP | -17.3 mmHg | Standard Deviation 10.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM 24-hour Mean SBP | -20.5 mmHg | Standard Deviation 13.9 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM 24-hour Mean SBP | -19.5 mmHg | Standard Deviation 11.6 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM 24-hour Mean SBP | -22.4 mmHg | Standard Deviation 9.8 |
Secondary
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Observed results for mod-sev patients - key combination therapies
Time frame: Up to 8 weeks (LOCF)
Population: FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 18 | -11.8 mmHg | Standard Deviation 15.6 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 2 | -8.8 mmHg | Standard Deviation 12.3 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 6 | -10.5 mmHg | Standard Deviation 12.2 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 8 | -13.3 mmHg | Standard Deviation 13.1 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 21 | -10.5 mmHg | Standard Deviation 12.3 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 3 | -11.2 mmHg | Standard Deviation 14.4 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 13 | -9.7 mmHg | Standard Deviation 13 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 15 | -10.5 mmHg | Standard Deviation 16.6 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 11 | -11.4 mmHg | Standard Deviation 13.9 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 4 | -10.7 mmHg | Standard Deviation 12.4 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 16 | -10.9 mmHg | Standard Deviation 15 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 23 | -10 mmHg | Standard Deviation 11.8 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 20 | -10 mmHg | Standard Deviation 12.3 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 5 | -12.8 mmHg | Standard Deviation 10.5 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 17 | -10.1 mmHg | Standard Deviation 14.1 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 9 | -14 mmHg | Standard Deviation 11 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 22 | -10.9 mmHg | Standard Deviation 11.3 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 7 | -13.8 mmHg | Standard Deviation 11.1 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 14 | -8.5 mmHg | Standard Deviation 14.3 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 1 | -11 mmHg | Standard Deviation 10.8 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 24 | -9.7 mmHg | Standard Deviation 9.8 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 12 | -12.4 mmHg | Standard Deviation 12.2 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 19 | -9 mmHg | Standard Deviation 11.7 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 10 | -10.7 mmHg | Standard Deviation 11.1 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 3 | -13.8 mmHg | Standard Deviation 11.2 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 12 | -13.9 mmHg | Standard Deviation 12.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 11 | -14.8 mmHg | Standard Deviation 12.6 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 24 | -13.6 mmHg | Standard Deviation 11.2 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 17 | -9.8 mmHg | Standard Deviation 14.9 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 13 | -14.9 mmHg | Standard Deviation 14.5 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 14 | -14.5 mmHg | Standard Deviation 14.6 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 15 | -10.5 mmHg | Standard Deviation 13.6 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 22 | -10 mmHg | Standard Deviation 14.6 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 16 | -10.3 mmHg | Standard Deviation 16.3 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 18 | -9.9 mmHg | Standard Deviation 13.5 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 1 | -16.9 mmHg | Standard Deviation 10.8 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 21 | -8.6 mmHg | Standard Deviation 14.3 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 2 | -16.3 mmHg | Standard Deviation 12.5 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 10 | -14.6 mmHg | Standard Deviation 14 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 6 | -15.3 mmHg | Standard Deviation 12.6 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 20 | -10.9 mmHg | Standard Deviation 13.1 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 4 | -16.3 mmHg | Standard Deviation 13.6 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 23 | -14 mmHg | Standard Deviation 13.8 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 5 | -15.3 mmHg | Standard Deviation 14.3 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 19 | -11.6 mmHg | Standard Deviation 13.9 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 7 | -15.3 mmHg | Standard Deviation 11.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 8 | -19.4 mmHg | Standard Deviation 13.7 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 9 | -16.6 mmHg | Standard Deviation 14.2 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 5 | -17.2 mmHg | Standard Deviation 14.3 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 18 | -10.6 mmHg | Standard Deviation 10.3 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 7 | -12.9 mmHg | Standard Deviation 10.9 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 8 | -13.5 mmHg | Standard Deviation 14.2 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 12 | -14.3 mmHg | Standard Deviation 12.2 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 15 | -13.8 mmHg | Standard Deviation 14.7 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 1 | -13.8 mmHg | Standard Deviation 10.1 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 2 | -13.9 mmHg | Standard Deviation 9.3 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 3 | -16.4 mmHg | Standard Deviation 11.3 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 4 | -15.9 mmHg | Standard Deviation 11.8 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 6 | -15.2 mmHg | Standard Deviation 10.1 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 9 | -15.8 mmHg | Standard Deviation 14.3 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 10 | -17 mmHg | Standard Deviation 14.2 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 11 | -16.8 mmHg | Standard Deviation 10.5 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 13 | -14.1 mmHg | Standard Deviation 12.5 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 14 | -15.1 mmHg | Standard Deviation 11.2 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 16 | -12.8 mmHg | Standard Deviation 12.2 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 17 | -11.5 mmHg | Standard Deviation 12.5 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 19 | -12.2 mmHg | Standard Deviation 10.6 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 20 | -13.3 mmHg | Standard Deviation 11.2 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 21 | -8.4 mmHg | Standard Deviation 12.1 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 22 | -10.2 mmHg | Standard Deviation 13.5 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 23 | -10 mmHg | Standard Deviation 12.5 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 24 | -13.2 mmHg | Standard Deviation 13.8 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 9 | -18.1 mmHg | Standard Deviation 14.1 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 6 | -16.3 mmHg | Standard Deviation 11.8 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 24 | -14.4 mmHg | Standard Deviation 12.2 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 19 | -12.5 mmHg | Standard Deviation 11.8 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 4 | -16.8 mmHg | Standard Deviation 11.3 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 3 | -16.1 mmHg | Standard Deviation 11.7 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 23 | -14.3 mmHg | Standard Deviation 8.5 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 20 | -15.7 mmHg | Standard Deviation 11.5 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 2 | -15.9 mmHg | Standard Deviation 13 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 1 | -13.7 mmHg | Standard Deviation 10.3 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 7 | -17.5 mmHg | Standard Deviation 14.6 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 21 | -15.1 mmHg | Standard Deviation 9.4 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 18 | -12.8 mmHg | Standard Deviation 10.8 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 15 | -10 mmHg | Standard Deviation 12.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 5 | -16.6 mmHg | Standard Deviation 10.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 22 | -15.2 mmHg | Standard Deviation 10.2 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 14 | -12 mmHg | Standard Deviation 14.6 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 12 | -16.6 mmHg | Standard Deviation 12.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 16 | -13.7 mmHg | Standard Deviation 13 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 13 | -15.9 mmHg | Standard Deviation 10.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 11 | -17.9 mmHg | Standard Deviation 12.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 8 | -17.8 mmHg | Standard Deviation 13.7 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 17 | -12.3 mmHg | Standard Deviation 10.8 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 10 | -20.8 mmHg | Standard Deviation 13.2 |
Secondary
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP
Observed results - key combination therapies
Time frame: End-of-study (up to 8 weeks) visit (LOCF)
Population: FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 10 | -11.8 mmHg | Standard Deviation 10.3 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 5 | -13.1 mmHg | Standard Deviation 11 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 3 | -11.2 mmHg | Standard Deviation 13.2 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 9 | -13.1 mmHg | Standard Deviation 10.3 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 24 | -11.1 mmHg | Standard Deviation 9.5 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 6 | -10.9 mmHg | Standard Deviation 11.6 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 4 | -11.3 mmHg | Standard Deviation 11.8 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 8 | -12.1 mmHg | Standard Deviation 12.3 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 1 | -10.7 mmHg | Standard Deviation 9.5 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 7 | -12.8 mmHg | Standard Deviation 10.2 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 21 | -10.4 mmHg | Standard Deviation 13 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 18 | -11.9 mmHg | Standard Deviation 15 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 17 | -9.8 mmHg | Standard Deviation 13.7 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 13 | -10.3 mmHg | Standard Deviation 11.7 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 16 | -10.1 mmHg | Standard Deviation 15 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 22 | -11.1 mmHg | Standard Deviation 12.6 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 15 | -10.3 mmHg | Standard Deviation 16 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 12 | -12 mmHg | Standard Deviation 11.3 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 11 | -11.2 mmHg | Standard Deviation 12.9 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 23 | -9.8 mmHg | Standard Deviation 11.3 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 20 | -11 mmHg | Standard Deviation 11.9 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 19 | -9.1 mmHg | Standard Deviation 10.9 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 2 | -9.8 mmHg | Standard Deviation 11.7 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 14 | -8.9 mmHg | Standard Deviation 13.2 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 1 | -15.4 mmHg | Standard Deviation 11.6 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 18 | -9.9 mmHg | Standard Deviation 12.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 19 | -10.5 mmHg | Standard Deviation 13.7 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 20 | -9.9 mmHg | Standard Deviation 12.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 21 | -8.9 mmHg | Standard Deviation 13.2 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 4 | -16.5 mmHg | Standard Deviation 13.2 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 22 | -9.8 mmHg | Standard Deviation 13.7 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 23 | -13.3 mmHg | Standard Deviation 13.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 24 | -12.6 mmHg | Standard Deviation 11.5 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 5 | -14.1 mmHg | Standard Deviation 14.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 6 | -14.5 mmHg | Standard Deviation 12.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 7 | -15.6 mmHg | Standard Deviation 13.9 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 8 | -17.4 mmHg | Standard Deviation 13.6 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 9 | -15.7 mmHg | Standard Deviation 14.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 14 | -14.8 mmHg | Standard Deviation 14.1 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 10 | -13.8 mmHg | Standard Deviation 13.5 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 11 | -14.4 mmHg | Standard Deviation 11.9 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 2 | -15 mmHg | Standard Deviation 12.2 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 12 | -13.3 mmHg | Standard Deviation 12.9 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 13 | -14.7 mmHg | Standard Deviation 14.3 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 15 | -11.5 mmHg | Standard Deviation 14.3 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 16 | -10.3 mmHg | Standard Deviation 15.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 3 | -14.1 mmHg | Standard Deviation 12.6 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 17 | -10.4 mmHg | Standard Deviation 14.4 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 24 | -12 mmHg | Standard Deviation 13.1 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 4 | -15.6 mmHg | Standard Deviation 11.7 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 19 | -11.9 mmHg | Standard Deviation 10.4 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 11 | -15.1 mmHg | Standard Deviation 13.1 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 3 | -14.8 mmHg | Standard Deviation 11.6 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 22 | -9.7 mmHg | Standard Deviation 12.9 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 16 | -11.3 mmHg | Standard Deviation 12 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 12 | -12.5 mmHg | Standard Deviation 14.8 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 2 | -13.4 mmHg | Standard Deviation 9.5 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 21 | -8.5 mmHg | Standard Deviation 12.7 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 17 | -11.2 mmHg | Standard Deviation 12.5 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 13 | -14.1 mmHg | Standard Deviation 13.5 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 7 | -12.9 mmHg | Standard Deviation 10.4 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 6 | -14.6 mmHg | Standard Deviation 9.9 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 18 | -10.3 mmHg | Standard Deviation 12.3 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 8 | -12.7 mmHg | Standard Deviation 13.6 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 1 | -12.7 mmHg | Standard Deviation 9.9 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 5 | -16.3 mmHg | Standard Deviation 14.3 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 14 | -13.4 mmHg | Standard Deviation 13.4 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 9 | -14.3 mmHg | Standard Deviation 14.3 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 20 | -12.6 mmHg | Standard Deviation 11.1 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 15 | -11.9 mmHg | Standard Deviation 14.8 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 23 | -9.9 mmHg | Standard Deviation 12.2 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 10 | -14.7 mmHg | Standard Deviation 15.7 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 24 | -13.1 mmHg | Standard Deviation 11.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 15 | -10 mmHg | Standard Deviation 12.7 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 18 | -12.2 mmHg | Standard Deviation 11.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 23 | -14.6 mmHg | Standard Deviation 9.4 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 1 | -13.4 mmHg | Standard Deviation 9.7 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 2 | -14.6 mmHg | Standard Deviation 12.4 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 3 | -15.4 mmHg | Standard Deviation 12 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 4 | -15.8 mmHg | Standard Deviation 10.8 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 5 | -15.7 mmHg | Standard Deviation 10.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 6 | -16.4 mmHg | Standard Deviation 11 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 7 | -15.7 mmHg | Standard Deviation 14 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 8 | -17.1 mmHg | Standard Deviation 12.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 9 | -17.2 mmHg | Standard Deviation 13.8 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 10 | -18.5 mmHg | Standard Deviation 12.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 11 | -16.1 mmHg | Standard Deviation 12.8 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 12 | -15.7 mmHg | Standard Deviation 12.2 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 13 | -15.1 mmHg | Standard Deviation 10.6 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 14 | -11 mmHg | Standard Deviation 14.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 16 | -12.2 mmHg | Standard Deviation 13.6 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 17 | -11.5 mmHg | Standard Deviation 13.1 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 19 | -13.2 mmHg | Standard Deviation 11.3 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 20 | -15.9 mmHg | Standard Deviation 11.1 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 21 | -14.8 mmHg | Standard Deviation 9.7 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) DBP | Hour 22 | -15.4 mmHg | Standard Deviation 9.9 |
Secondary
Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP
Observed results - key combination therapies
Time frame: End-of-study (up to 8 weeks) visit (LOCF)
Population: FAS-ABPM: all patients of the FAS that participated in the ambulatory blood pressure monitoring (ABPM) sub-study and had a successful APBM at both baseline and following treatment with target therapy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 10 | -20.0 mmHg | Standard Deviation 16 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 4 | -18.0 mmHg | Standard Deviation 16.9 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 20 | -17.8 mmHg | Standard Deviation 16.4 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 9 | -20.3 mmHg | Standard Deviation 15.6 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 7 | -17.8 mmHg | Standard Deviation 14.5 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 5 | -19.3 mmHg | Standard Deviation 13.6 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 6 | -14.1 mmHg | Standard Deviation 14 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 16 | -17.0 mmHg | Standard Deviation 16.9 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 22 | -16.2 mmHg | Standard Deviation 15.9 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 19 | -16.5 mmHg | Standard Deviation 15.6 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 18 | -17.5 mmHg | Standard Deviation 18.6 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 17 | -17.3 mmHg | Standard Deviation 17.3 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 24 | -15.8 mmHg | Standard Deviation 14.9 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 1 | -18.7 mmHg | Standard Deviation 12.9 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 8 | -18.8 mmHg | Standard Deviation 17.1 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 15 | -15.7 mmHg | Standard Deviation 18.1 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 14 | -16.7 mmHg | Standard Deviation 17.6 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 2 | -13.1 mmHg | Standard Deviation 16.5 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 23 | -14.4 mmHg | Standard Deviation 14.6 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 13 | -18.5 mmHg | Standard Deviation 16.9 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 12 | -18.4 mmHg | Standard Deviation 16.8 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 3 | -15.3 mmHg | Standard Deviation 16.1 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 21 | -17.5 mmHg | Standard Deviation 15.9 |
| Telmisartan 0 mg (T0) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 11 | -18.7 mmHg | Standard Deviation 17.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 14 | -21.6 mmHg | Standard Deviation 20.8 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 8 | -24.1 mmHg | Standard Deviation 20.8 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 16 | -17.7 mmHg | Standard Deviation 20 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 1 | -20.2 mmHg | Standard Deviation 16.5 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 2 | -22.0 mmHg | Standard Deviation 17.9 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 3 | -17.9 mmHg | Standard Deviation 18.9 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 4 | -24.4 mmHg | Standard Deviation 20.6 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 6 | -22.6 mmHg | Standard Deviation 14.9 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 7 | -24.3 mmHg | Standard Deviation 19.5 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 9 | -24.9 mmHg | Standard Deviation 20 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 10 | -22.9 mmHg | Standard Deviation 19.2 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 11 | -20.9 mmHg | Standard Deviation 19.8 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 12 | -20.3 mmHg | Standard Deviation 19.5 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 13 | -21.7 mmHg | Standard Deviation 23.5 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 5 | -21.1 mmHg | Standard Deviation 19.8 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 15 | -19.4 mmHg | Standard Deviation 20.5 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 17 | -17.9 mmHg | Standard Deviation 20.3 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 18 | -17.4 mmHg | Standard Deviation 16.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 19 | -19.7 mmHg | Standard Deviation 18.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 20 | -18.0 mmHg | Standard Deviation 17.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 21 | -17.8 mmHg | Standard Deviation 17.6 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 22 | -15.7 mmHg | Standard Deviation 17 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 23 | -18.9 mmHg | Standard Deviation 16.1 |
| Telmisartan 20 mg (T20) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 24 | -20.7 mmHg | Standard Deviation 16.3 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 22 | -15.5 mmHg | Standard Deviation 18.7 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 18 | -15.1 mmHg | Standard Deviation 16.8 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 14 | -21.7 mmHg | Standard Deviation 19.2 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 16 | -18.0 mmHg | Standard Deviation 16 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 2 | -20.5 mmHg | Standard Deviation 16.6 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 19 | -16.9 mmHg | Standard Deviation 15.3 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 8 | -20.3 mmHg | Standard Deviation 18.6 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 1 | -19.1 mmHg | Standard Deviation 13.4 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 6 | -21.6 mmHg | Standard Deviation 15.9 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 21 | -15.7 mmHg | Standard Deviation 16.4 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 15 | -19.0 mmHg | Standard Deviation 20.2 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 5 | -25.3 mmHg | Standard Deviation 18.1 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 7 | -19.9 mmHg | Standard Deviation 17.7 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 13 | -22.7 mmHg | Standard Deviation 18.3 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 24 | -18.5 mmHg | Standard Deviation 18.1 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 4 | -22.5 mmHg | Standard Deviation 16.5 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 20 | -16.5 mmHg | Standard Deviation 15.3 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 9 | -22.0 mmHg | Standard Deviation 19.2 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 12 | -19.7 mmHg | Standard Deviation 19.1 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 17 | -14.7 mmHg | Standard Deviation 15.8 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 11 | -23.2 mmHg | Standard Deviation 16.7 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 10 | -22.5 mmHg | Standard Deviation 19.3 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 23 | -16.5 mmHg | Standard Deviation 19.1 |
| Telmisartan 40 mg (T40) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 3 | -21.1 mmHg | Standard Deviation 17.8 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 19 | -20.9 mmHg | Standard Deviation 17.3 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 11 | -24.9 mmHg | Standard Deviation 15.7 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 2 | -21.9 mmHg | Standard Deviation 15.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 12 | -25.0 mmHg | Standard Deviation 17.3 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 13 | -24.7 mmHg | Standard Deviation 14.6 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 1 | -17.5 mmHg | Standard Deviation 15.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 21 | -22.7 mmHg | Standard Deviation 15 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 14 | -20.2 mmHg | Standard Deviation 16.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 5 | -24.0 mmHg | Standard Deviation 16.5 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 16 | -19.8 mmHg | Standard Deviation 15.4 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 23 | -22.4 mmHg | Standard Deviation 14 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 24 | -19.9 mmHg | Standard Deviation 13.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 17 | -19.1 mmHg | Standard Deviation 15.5 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 18 | -19.6 mmHg | Standard Deviation 16.6 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 22 | -23.8 mmHg | Standard Deviation 13.8 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 15 | -18.9 mmHg | Standard Deviation 15.1 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 6 | -24.6 mmHg | Standard Deviation 14.8 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 4 | -23.8 mmHg | Standard Deviation 15.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 7 | -22.4 mmHg | Standard Deviation 15.6 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 8 | -21.8 mmHg | Standard Deviation 15.5 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 9 | -25.6 mmHg | Standard Deviation 16.1 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 3 | -22.4 mmHg | Standard Deviation 16.8 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 20 | -24.4 mmHg | Standard Deviation 14.3 |
| Telmisartan 80 mg (T80) | Change From Baseline in ABPM Hourly Mean (Relative to Dosing) SBP | Hour 10 | -26.8 mmHg | Standard Deviation 19.3 |
Secondary
Change From Baseline in Seated Trough Cuff Mean SBP
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.
Time frame: Up to 8 weeks (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in Seated Trough Cuff Mean SBP | -1.9 mmHg | Standard Error 2.1 |
| Telmisartan 20 mg (T20) | Change From Baseline in Seated Trough Cuff Mean SBP | -15.6 mmHg | Standard Error 2.1 |
| Telmisartan 40 mg (T40) | Change From Baseline in Seated Trough Cuff Mean SBP | -15.4 mmHg | Standard Error 1.2 |
| Telmisartan 80 mg (T80) | Change From Baseline in Seated Trough Cuff Mean SBP | -15.4 mmHg | Standard Error 1.3 |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Change From Baseline in Seated Trough Cuff Mean SBP | -19 mmHg | Standard Error 2.1 |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Change From Baseline in Seated Trough Cuff Mean SBP | -22.1 mmHg | Standard Error 2.1 |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Change From Baseline in Seated Trough Cuff Mean SBP | -25.2 mmHg | Standard Error 2.3 |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Change From Baseline in Seated Trough Cuff Mean SBP | -23.2 mmHg | Standard Error 2.2 |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Change From Baseline in Seated Trough Cuff Mean SBP | -22.2 mmHg | Standard Error 1.2 |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Change From Baseline in Seated Trough Cuff Mean SBP | -25.3 mmHg | Standard Error 1.3 |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Change From Baseline in Seated Trough Cuff Mean SBP | -17.4 mmHg | Standard Error 2 |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Change From Baseline in Seated Trough Cuff Mean SBP | -22.5 mmHg | Standard Error 1.2 |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Change From Baseline in Seated Trough Cuff Mean SBP | -26.5 mmHg | Standard Error 1.2 |
| Amlodipine 2.5 mg (A2.5) | Change From Baseline in Seated Trough Cuff Mean SBP | -12.4 mmHg | Standard Error 2 |
| Amlodipine 5 mg (A5) | Change From Baseline in Seated Trough Cuff Mean SBP | -14.8 mmHg | Standard Error 1.2 |
| Amlodipine 10 mg (A10) | Change From Baseline in Seated Trough Cuff Mean SBP | -21 mmHg | Standard Error 1.4 |
Secondary
Change From Baseline in Seated Trough Pulse Rate
Observed results for mod-sev patients - key combination therapies
Time frame: Up to 8 weeks (LOCF)
Population: The full analysis set relating to the in-clinic trough pulse rate measurements included all treated patients that had at least one in-clinic pulse rate measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in Seated Trough Pulse Rate | 0.5 bpm | Standard Deviation 8.8 |
| Telmisartan 20 mg (T20) | Change From Baseline in Seated Trough Pulse Rate | 0 bpm | Standard Deviation 9 |
| Telmisartan 40 mg (T40) | Change From Baseline in Seated Trough Pulse Rate | 2.5 bpm | Standard Deviation 9.2 |
| Telmisartan 80 mg (T80) | Change From Baseline in Seated Trough Pulse Rate | -1.9 bpm | Standard Deviation 8.9 |
Secondary
Change From Baseline in Seated Trough Pulse Rate
Observed results for all patients - key combination therapies
Time frame: End-of-study visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff Pulse Rate measurements included all treated patients that had at least one Pulse Rate measurement following treatment with target therapy (FAS-TC)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in Seated Trough Pulse Rate | 0 bpm | Standard Deviation 8.8 |
| Telmisartan 20 mg (T20) | Change From Baseline in Seated Trough Pulse Rate | 0 bpm | Standard Deviation 9.5 |
| Telmisartan 40 mg (T40) | Change From Baseline in Seated Trough Pulse Rate | 2.4 bpm | Standard Deviation 9.3 |
| Telmisartan 80 mg (T80) | Change From Baseline in Seated Trough Pulse Rate | -1.5 bpm | Standard Deviation 9.7 |
Secondary
Change From Baseline in Standing Trough Cuff Mean DBP
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline DBP included as a covariate.
Time frame: Up to 8 weeks (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in Standing Trough Cuff Mean DBP | -4.2 mmHg | Standard Error 1.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in Standing Trough Cuff Mean DBP | -11.7 mmHg | Standard Error 1.5 |
| Telmisartan 40 mg (T40) | Change From Baseline in Standing Trough Cuff Mean DBP | -10.9 mmHg | Standard Error 0.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in Standing Trough Cuff Mean DBP | -11.3 mmHg | Standard Error 0.9 |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Change From Baseline in Standing Trough Cuff Mean DBP | -15.1 mmHg | Standard Error 1.4 |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Change From Baseline in Standing Trough Cuff Mean DBP | -13.3 mmHg | Standard Error 1.4 |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Change From Baseline in Standing Trough Cuff Mean DBP | -17.6 mmHg | Standard Error 1.6 |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Change From Baseline in Standing Trough Cuff Mean DBP | -17.5 mmHg | Standard Error 1.5 |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Change From Baseline in Standing Trough Cuff Mean DBP | -14.2 mmHg | Standard Error 0.8 |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Change From Baseline in Standing Trough Cuff Mean DBP | -18 mmHg | Standard Error 0.9 |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Change From Baseline in Standing Trough Cuff Mean DBP | -14.5 mmHg | Standard Error 1.4 |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Change From Baseline in Standing Trough Cuff Mean DBP | -17.3 mmHg | Standard Error 0.8 |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Change From Baseline in Standing Trough Cuff Mean DBP | -19.2 mmHg | Standard Error 0.8 |
| Amlodipine 2.5 mg (A2.5) | Change From Baseline in Standing Trough Cuff Mean DBP | -8 mmHg | Standard Error 1.4 |
| Amlodipine 5 mg (A5) | Change From Baseline in Standing Trough Cuff Mean DBP | -11 mmHg | Standard Error 0.8 |
| Amlodipine 10 mg (A10) | Change From Baseline in Standing Trough Cuff Mean DBP | -15.5 mmHg | Standard Error 0.9 |
Secondary
Change From Baseline in Standing Trough Cuff Mean SBP
Results stem from an ANCOVA including the main effects of treatment with telmisartan, treatment with amlodipine, and country/region with baseline SBP included as a covariate.
Time frame: Up to 8 weeks (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in Standing Trough Cuff Mean SBP | 1 mmHg | Standard Error 2.1 |
| Telmisartan 20 mg (T20) | Change From Baseline in Standing Trough Cuff Mean SBP | -13.7 mmHg | Standard Error 2.1 |
| Telmisartan 40 mg (T40) | Change From Baseline in Standing Trough Cuff Mean SBP | -13.6 mmHg | Standard Error 1.2 |
| Telmisartan 80 mg (T80) | Change From Baseline in Standing Trough Cuff Mean SBP | -14 mmHg | Standard Error 1.3 |
| Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5) | Change From Baseline in Standing Trough Cuff Mean SBP | -16.2 mmHg | Standard Error 2.1 |
| Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5) | Change From Baseline in Standing Trough Cuff Mean SBP | -19.4 mmHg | Standard Error 2.1 |
| Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10) | Change From Baseline in Standing Trough Cuff Mean SBP | -23.2 mmHg | Standard Error 2.3 |
| Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5) | Change From Baseline in Standing Trough Cuff Mean SBP | -21.8 mmHg | Standard Error 2.2 |
| Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5) | Change From Baseline in Standing Trough Cuff Mean SBP | -20.4 mmHg | Standard Error 1.2 |
| Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10) | Change From Baseline in Standing Trough Cuff Mean SBP | -22.8 mmHg | Standard Error 1.3 |
| Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5) | Change From Baseline in Standing Trough Cuff Mean SBP | -16.3 mmHg | Standard Error 2 |
| Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5) | Change From Baseline in Standing Trough Cuff Mean SBP | -21.9 mmHg | Standard Error 1.2 |
| Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10) | Change From Baseline in Standing Trough Cuff Mean SBP | -24.3 mmHg | Standard Error 1.2 |
| Amlodipine 2.5 mg (A2.5) | Change From Baseline in Standing Trough Cuff Mean SBP | -10.1 mmHg | Standard Error 2.1 |
| Amlodipine 5 mg (A5) | Change From Baseline in Standing Trough Cuff Mean SBP | -13.2 mmHg | Standard Error 1.2 |
| Amlodipine 10 mg (A10) | Change From Baseline in Standing Trough Cuff Mean SBP | -19.3 mmHg | Standard Error 1.4 |
Secondary
Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG)
Clinical relevant abnormalities for laboratory parameters and Electrocardiogram (ECG). New abnormal findings or worsening of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).
Time frame: 8 weeks
Population: Treated set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | QRS axis abnormal | 0.0 percentage of participants |
| Telmisartan 0 mg (T0) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Palpitation | 0.0 percentage of participants |
| Telmisartan 0 mg (T0) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Blood potassium increased | 0.0 percentage of participants |
| Telmisartan 0 mg (T0) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Sinus bradycardia | 0.0 percentage of participants |
| Telmisartan 0 mg (T0) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Electrocardiogram QT shortened | 0.0 percentage of participants |
| Telmisartan 0 mg (T0) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Myocardial ischaemia | 0.0 percentage of participants |
| Telmisartan 0 mg (T0) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Atrioventricular block first degree | 0.0 percentage of participants |
| Telmisartan 0 mg (T0) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Alanine aminotransferase increased | 0.0 percentage of participants |
| Telmisartan 0 mg (T0) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Electrocardiogram T wave abnormal | 0.0 percentage of participants |
| Telmisartan 0 mg (T0) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Heart rate irregular | 0.0 percentage of participants |
| Telmisartan 0 mg (T0) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Left atrial dilatation | 0.0 percentage of participants |
| Telmisartan 0 mg (T0) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Aspartate aminotransferase increased | 0.0 percentage of participants |
| Telmisartan 0 mg (T0) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Electrocardiogram repolarisation abnormality | 0.0 percentage of participants |
| Telmisartan 20 mg (T20) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Aspartate aminotransferase increased | 0.3 percentage of participants |
| Telmisartan 20 mg (T20) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Heart rate irregular | 0.0 percentage of participants |
| Telmisartan 20 mg (T20) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Myocardial ischaemia | 0.1 percentage of participants |
| Telmisartan 20 mg (T20) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | QRS axis abnormal | 0.0 percentage of participants |
| Telmisartan 20 mg (T20) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Sinus bradycardia | 0.0 percentage of participants |
| Telmisartan 20 mg (T20) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Palpitation | 0.0 percentage of participants |
| Telmisartan 20 mg (T20) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Alanine aminotransferase increased | 0.3 percentage of participants |
| Telmisartan 20 mg (T20) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Electrocardiogram repolarisation abnormality | 0.0 percentage of participants |
| Telmisartan 20 mg (T20) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Blood potassium increased | 0.3 percentage of participants |
| Telmisartan 20 mg (T20) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Electrocardiogram QT shortened | 0.0 percentage of participants |
| Telmisartan 20 mg (T20) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Left atrial dilatation | 0.0 percentage of participants |
| Telmisartan 20 mg (T20) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Electrocardiogram T wave abnormal | 0.0 percentage of participants |
| Telmisartan 20 mg (T20) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Atrioventricular block first degree | 0.0 percentage of participants |
| Telmisartan 40 mg (T40) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Alanine aminotransferase increased | 0.0 percentage of participants |
| Telmisartan 40 mg (T40) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Aspartate aminotransferase increased | 0.0 percentage of participants |
| Telmisartan 40 mg (T40) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Myocardial ischaemia | 0.0 percentage of participants |
| Telmisartan 40 mg (T40) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Blood potassium increased | 0.0 percentage of participants |
| Telmisartan 40 mg (T40) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Electrocardiogram QT shortened | 0.3 percentage of participants |
| Telmisartan 40 mg (T40) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Electrocardiogram T wave abnormal | 0.3 percentage of participants |
| Telmisartan 40 mg (T40) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Electrocardiogram repolarisation abnormality | 0.0 percentage of participants |
| Telmisartan 40 mg (T40) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Heart rate irregular | 0.3 percentage of participants |
| Telmisartan 40 mg (T40) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | QRS axis abnormal | 0.3 percentage of participants |
| Telmisartan 40 mg (T40) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Atrioventricular block first degree | 0.0 percentage of participants |
| Telmisartan 40 mg (T40) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Left atrial dilatation | 0.0 percentage of participants |
| Telmisartan 40 mg (T40) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Palpitation | 0.6 percentage of participants |
| Telmisartan 40 mg (T40) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Sinus bradycardia | 0.0 percentage of participants |
| Telmisartan 80 mg (T80) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Left atrial dilatation | 0.1 percentage of participants |
| Telmisartan 80 mg (T80) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Atrioventricular block first degree | 0.3 percentage of participants |
| Telmisartan 80 mg (T80) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Electrocardiogram QT shortened | 0.0 percentage of participants |
| Telmisartan 80 mg (T80) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Alanine aminotransferase increased | 0.1 percentage of participants |
| Telmisartan 80 mg (T80) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Blood potassium increased | 0.0 percentage of participants |
| Telmisartan 80 mg (T80) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Myocardial ischaemia | 0.0 percentage of participants |
| Telmisartan 80 mg (T80) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Aspartate aminotransferase increased | 0.1 percentage of participants |
| Telmisartan 80 mg (T80) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Sinus bradycardia | 0.1 percentage of participants |
| Telmisartan 80 mg (T80) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Heart rate irregular | 0.0 percentage of participants |
| Telmisartan 80 mg (T80) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Palpitation | 0.1 percentage of participants |
| Telmisartan 80 mg (T80) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | QRS axis abnormal | 0.0 percentage of participants |
| Telmisartan 80 mg (T80) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Electrocardiogram repolarisation abnormality | 0.1 percentage of participants |
| Telmisartan 80 mg (T80) | Clinical Relevant Abnormalities for Laboratory Parameters and Electrocardiogram (ECG) | Electrocardiogram T wave abnormal | 0.1 percentage of participants |
Secondary
DBP Control
DBP control is defined as DBP \< 90 mmHg - key combination therapies
Time frame: End-of-study (up to 8 weeks) visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 0 mg (T0) | DBP Control | 71.6 percentage of participants |
| Telmisartan 20 mg (T20) | DBP Control | 82.1 percentage of participants |
| Telmisartan 40 mg (T40) | DBP Control | 74.8 percentage of participants |
| Telmisartan 80 mg (T80) | DBP Control | 85.3 percentage of participants |
Secondary
DBP Control
DBP control is defined as DBP \< 90 mmHg - key combination therapies
Time frame: Up to 8 weeks (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 0 mg (T0) | DBP Control | 69.4 percentage of participants |
| Telmisartan 20 mg (T20) | DBP Control | 77.1 percentage of participants |
| Telmisartan 40 mg (T40) | DBP Control | 68.9 percentage of participants |
| Telmisartan 80 mg (T80) | DBP Control | 85 percentage of participants |
Secondary
DBP Response
DBP response is defined as DBP \< 90 mmHg or a reduction of DBP of \>= 10 mmHg - key combination therapies
Time frame: End-of-study (up to 8 weeks) visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 0 mg (T0) | DBP Response | 80.9 percentage of participants |
| Telmisartan 20 mg (T20) | DBP Response | 91.9 percentage of participants |
| Telmisartan 40 mg (T40) | DBP Response | 88.8 percentage of participants |
| Telmisartan 80 mg (T80) | DBP Response | 91.2 percentage of participants |
Secondary
DBP Response
DBP response is defined as DBP \< 90 mmHg or a reduction of DBP of \>= 10 mmHg - key combination therapies
Time frame: Up to 8 weeks (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 0 mg (T0) | DBP Response | 81.5 percentage of participants |
| Telmisartan 20 mg (T20) | DBP Response | 89.6 percentage of participants |
| Telmisartan 40 mg (T40) | DBP Response | 87.7 percentage of participants |
| Telmisartan 80 mg (T80) | DBP Response | 93 percentage of participants |
Secondary
Orthostatic Change in Trough Cuff Mean DBP
Calculated as seated minus standing for all patients - key combination therapies
Time frame: Week 8
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Diastolic Blood Pressure measurement following treatment with target therapy (FAS-TC)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Orthostatic Change in Trough Cuff Mean DBP | 2.2 mmHg | Standard Deviation 5.7 |
| Telmisartan 20 mg (T20) | Orthostatic Change in Trough Cuff Mean DBP | 1.7 mmHg | Standard Deviation 5.4 |
| Telmisartan 40 mg (T40) | Orthostatic Change in Trough Cuff Mean DBP | 2 mmHg | Standard Deviation 5.4 |
| Telmisartan 80 mg (T80) | Orthostatic Change in Trough Cuff Mean DBP | 1.1 mmHg | Standard Deviation 4.9 |
Secondary
Orthostatic Change in Trough Cuff Mean DBP
Calculated as seated minus standing for mod-sev patients - key combination therapies
Time frame: Week 8
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Orthostatic Change in Trough Cuff Mean DBP | 2.5 mmHg | Standard Deviation 5.1 |
| Telmisartan 20 mg (T20) | Orthostatic Change in Trough Cuff Mean DBP | 2 mmHg | Standard Deviation 5.7 |
| Telmisartan 40 mg (T40) | Orthostatic Change in Trough Cuff Mean DBP | 1.4 mmHg | Standard Deviation 5.3 |
| Telmisartan 80 mg (T80) | Orthostatic Change in Trough Cuff Mean DBP | 1.6 mmHg | Standard Deviation 4.5 |
Secondary
Orthostatic Change in Trough Cuff Mean SBP
Calculated as seated minus standing for all patients - key combination therapies
Time frame: Week 8
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Orthostatic Change in Trough Cuff Mean SBP | 0 mmHg | Standard Deviation 7.5 |
| Telmisartan 20 mg (T20) | Orthostatic Change in Trough Cuff Mean SBP | 0.6 mmHg | Standard Deviation 8 |
| Telmisartan 40 mg (T40) | Orthostatic Change in Trough Cuff Mean SBP | 0.9 mmHg | Standard Deviation 7.5 |
| Telmisartan 80 mg (T80) | Orthostatic Change in Trough Cuff Mean SBP | 0.8 mmHg | Standard Deviation 7.3 |
Secondary
Orthostatic Change in Trough Cuff Mean SBP
Calculated as seated minus standing for mod-sev patients - key combination therapies
Time frame: Week 8
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic systolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 0 mg (T0) | Orthostatic Change in Trough Cuff Mean SBP | 0 mmHg | Standard Deviation 7.1 |
| Telmisartan 20 mg (T20) | Orthostatic Change in Trough Cuff Mean SBP | 1.4 mmHg | Standard Deviation 8.1 |
| Telmisartan 40 mg (T40) | Orthostatic Change in Trough Cuff Mean SBP | 0.1 mmHg | Standard Deviation 6.9 |
| Telmisartan 80 mg (T80) | Orthostatic Change in Trough Cuff Mean SBP | 1.1 mmHg | Standard Deviation 6.3 |
Secondary
SBP Response
SBP Response is defined as SBP \< 140 mmHg or a reduction of SBP of \>= 10 mmHg - key combination therapies
Time frame: End-of-study (up to 8 weeks) visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy (FAS-TC)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 0 mg (T0) | SBP Response | 91.5 percentage of participants |
| Telmisartan 20 mg (T20) | SBP Response | 96.7 percentage of participants |
| Telmisartan 40 mg (T40) | SBP Response | 87.4 percentage of participants |
| Telmisartan 80 mg (T80) | SBP Response | 94.9 percentage of participants |
Secondary
SBP Response
SBP Response is defined as SBP \< 140 mmHg or a reduction of SBP of \>= 10 mmHg - key combination therapies
Time frame: Up to 8 weeks (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic Systolic Blood Pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 0 mg (T0) | SBP Response | 88.9 percentage of participants |
| Telmisartan 20 mg (T20) | SBP Response | 96.9 percentage of participants |
| Telmisartan 40 mg (T40) | SBP Response | 84.9 percentage of participants |
| Telmisartan 80 mg (T80) | SBP Response | 95 percentage of participants |
Other Pre-specified
BP Control
Responders SBP\<10 mmHg and DBP\<90 mmHg) for mod-sev patients - key combination therapies
Time frame: Up to 8 weeks (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic and systolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 0 mg (T0) | BP Control | 53.7 percentage of participants |
| Telmisartan 20 mg (T20) | BP Control | 70.8 percentage of participants |
| Telmisartan 40 mg (T40) | BP Control | 58.5 percentage of participants |
| Telmisartan 80 mg (T80) | BP Control | 77 percentage of participants |
Other Pre-specified
BP Control
Percentage of responders (SBP\<140 mmHg and DBP\<90 mmHg) for all patients - key combination therapies
Time frame: End-of-study (up to 8 weeks) visit (LOCF)
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic and systolic blood pressure measurement following treatment with target therapy (FAS-TC).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan 0 mg (T0) | BP Control | 58.9 percentage of participants |
| Telmisartan 20 mg (T20) | BP Control | 75.6 percentage of participants |
| Telmisartan 40 mg (T40) | BP Control | 65.7 percentage of participants |
| Telmisartan 80 mg (T80) | BP Control | 76.5 percentage of participants |
Other Pre-specified
Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP
Observed results for key combination therapies
Time frame: Baseline to nominal week over the trial
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy (FAS-TC).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 4 (N=133, 115, 135, 129) | -16.0 mmHg | Standard Deviation 7.24 |
| Telmisartan 0 mg (T0) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 6 (N=134, 118, 131, 124) | -17.1 mmHg | Standard Deviation 8.59 |
| Telmisartan 0 mg (T0) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 8 (N=133, 112, 132, 121) | -16.3 mmHg | Standard Deviation 7.42 |
| Telmisartan 0 mg (T0) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 2 | -14.5 mmHg | Standard Deviation 8.76 |
| Telmisartan 20 mg (T20) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 4 (N=133, 115, 135, 129) | -18.1 mmHg | Standard Deviation 8.52 |
| Telmisartan 20 mg (T20) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 2 | -14.4 mmHg | Standard Deviation 7.62 |
| Telmisartan 20 mg (T20) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 6 (N=134, 118, 131, 124) | -19.0 mmHg | Standard Deviation 8.3 |
| Telmisartan 20 mg (T20) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 8 (N=133, 112, 132, 121) | -19.5 mmHg | Standard Deviation 8.03 |
| Telmisartan 40 mg (T40) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 6 (N=134, 118, 131, 124) | -18.0 mmHg | Standard Deviation 8.02 |
| Telmisartan 40 mg (T40) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 8 (N=133, 112, 132, 121) | -18.3 mmHg | Standard Deviation 8.28 |
| Telmisartan 40 mg (T40) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 2 | -15.3 mmHg | Standard Deviation 7.87 |
| Telmisartan 40 mg (T40) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 4 (N=133, 115, 135, 129) | -17.2 mmHg | Standard Deviation 7.56 |
| Telmisartan 80 mg (T80) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 8 (N=133, 112, 132, 121) | -20.0 mmHg | Standard Deviation 7.61 |
| Telmisartan 80 mg (T80) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 6 (N=134, 118, 131, 124) | -20.0 mmHg | Standard Deviation 8.18 |
| Telmisartan 80 mg (T80) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 2 | -14.6 mmHg | Standard Deviation 6.76 |
| Telmisartan 80 mg (T80) | Change From Baseline at 2,4,6,and 8 Weeks in Seated Trough Cuff DBP | Week 4 (N=133, 115, 135, 129) | -18.8 mmHg | Standard Deviation 7.06 |
Other Pre-specified
Change From Baseline in Seated Trough Cuff DBP
Observed results for mod-sev patients - key combination therapies
Time frame: Nominal week over the trial
Population: The full analysis set relating to the in-clinic trough cuff blood pressure measurements included all treated patients that had at least one in-clinic diastolic blood pressure measurement following treatment with target therapy and were identified as having moderate or severe hypertension at baseline (FAS-TC-MS).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Telmisartan 0 mg (T0) | Change From Baseline in Seated Trough Cuff DBP | Week 2 | -14.7 mmHg | Standard Deviation 8.9 |
| Telmisartan 0 mg (T0) | Change From Baseline in Seated Trough Cuff DBP | Week 4 (N=102, 90, 102, 96) | -16.5 mmHg | Standard Deviation 6.8 |
| Telmisartan 0 mg (T0) | Change From Baseline in Seated Trough Cuff DBP | Week 6 (N=102, 92, 98, 96) | -17.9 mmHg | Standard Deviation 7.8 |
| Telmisartan 0 mg (T0) | Change From Baseline in Seated Trough Cuff DBP | Week 8 (N=102, 87, 99, 88) | -17.1 mmHg | Standard Deviation 7.4 |
| Telmisartan 20 mg (T20) | Change From Baseline in Seated Trough Cuff DBP | Week 4 (N=102, 90, 102, 96) | -18.2 mmHg | Standard Deviation 9.2 |
| Telmisartan 20 mg (T20) | Change From Baseline in Seated Trough Cuff DBP | Week 6 (N=102, 92, 98, 96) | -19.7 mmHg | Standard Deviation 8.7 |
| Telmisartan 20 mg (T20) | Change From Baseline in Seated Trough Cuff DBP | Week 8 (N=102, 87, 99, 88) | -19.4 mmHg | Standard Deviation 8.5 |
| Telmisartan 20 mg (T20) | Change From Baseline in Seated Trough Cuff DBP | Week 2 | -14.7 mmHg | Standard Deviation 7.8 |
| Telmisartan 40 mg (T40) | Change From Baseline in Seated Trough Cuff DBP | Week 6 (N=102, 92, 98, 96) | -18.9 mmHg | Standard Deviation 8.2 |
| Telmisartan 40 mg (T40) | Change From Baseline in Seated Trough Cuff DBP | Week 4 (N=102, 90, 102, 96) | -17.8 mmHg | Standard Deviation 7.6 |
| Telmisartan 40 mg (T40) | Change From Baseline in Seated Trough Cuff DBP | Week 8 (N=102, 87, 99, 88) | -19.3 mmHg | Standard Deviation 8.7 |
| Telmisartan 40 mg (T40) | Change From Baseline in Seated Trough Cuff DBP | Week 2 | -16.1 mmHg | Standard Deviation 7.9 |
| Telmisartan 80 mg (T80) | Change From Baseline in Seated Trough Cuff DBP | Week 8 (N=102, 87, 99, 88) | -21.1 mmHg | Standard Deviation 7.1 |
| Telmisartan 80 mg (T80) | Change From Baseline in Seated Trough Cuff DBP | Week 4 (N=102, 90, 102, 96) | -19.2 mmHg | Standard Deviation 6.8 |
| Telmisartan 80 mg (T80) | Change From Baseline in Seated Trough Cuff DBP | Week 2 | -14.9 mmHg | Standard Deviation 6.7 |
| Telmisartan 80 mg (T80) | Change From Baseline in Seated Trough Cuff DBP | Week 6 (N=102, 92, 98, 96) | -19.5 mmHg | Standard Deviation 8.4 |