Hypertension
Conditions
Brief summary
The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure \[SBP\] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.
Interventions
DRUGamlodipine
amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w
DRUGtelmisartan
telmisartan 80mg for the 8w, no titration required
telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation 2. Age 18 years or older 3. Patients with severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation 4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigators discretion)
Exclusion criteria
Mean in-clinic seated cuff SBP \>/= 200 mmHg and/or Diastolic Blood Pressure \[DBP\] \>/= 95 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 | baseline and week 8 | Overall mean reduction from a common mean baseline in SBP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 | baseline and week 4 | Overall mean reduction from a common mean baseline in SBP |
| Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2 | baseline and week 2 | Overall mean reduction from a common mean baseline in SBP |
| Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1 | baseline and week 1 | Overall mean reduction from a common mean baseline in SBP |
| Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8 | baseline and week 8 | Overall mean reduction from a common mean baseline in DBP |
| Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6 | baseline and week 6 | Overall mean reduction from a common mean baseline in DBP |
| Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4 | baseline and week 4 | Overall mean reduction from a common mean baseline in DBP |
| Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2 | baseline and week 2 | Overall mean reduction from a common mean baseline in DBP |
| Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1 | baseline and week 1 | Overall mean reduction from a common mean baseline in DBP |
| Patients Achieving Diastolic Blood Pressure Control at Week 1 | week 1 | Diastolic Blood Pressure Control is defined as achieving DBP \< 90mmHg |
| Patients Achieving Diastolic Blood Pressure Control at Week 2 | week 2 | DBP \< 90 mmHg |
| Patients Achieving Blood Pressure Control at Week 1 | week 1 | Blood Pressure Control is defined as achieving SBP\< 140 mmHg and DBP \< 90mmHg |
| Patients Achieving Blood Pressure Control at Week 2 | week 2 | SBP \< 140 mmHg and DBP \< 90 mmHg |
| Patients Achieving Diastolic Blood Pressure Response at Week 1 | baseline, week 1 | Diastolic Blood Pressure Response is defined as achieving DBP \< 90 mmHg or a reduction of \>= 10 mmHg |
| Patients Achieving Diastolic Blood Pressure Response at Week 2 | baseline, week 2 | DBP \< 90 mmHg or reduction of \>= 10 mmHg |
| Patients Achieving Systolic Blood Pressure Response at Week 1 | baseline, week 1 | Systolic Blood Pressure Response Control is defined as achieving SBP \< 140 mmHg or a reduction of \>= 15 mmHg |
| Patients Achieving Systolic Blood Pressure Response at Week 2 | baseline, week 2 | SBP \< 140 mmHg or reduction of \>= 15 mmHg |
| Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 | baseline and week 6 | Overall mean reduction from a common mean baseline in SBP |
| Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 | week 2 | Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90 |
| Patients Achieving Diastolic Blood Pressure Control at Week 4 | week 4 | DBP \< 90 mmHg |
| Patients Achieving Diastolic Blood Pressure Control at Week 6 | week 6 | DBP \< 90 mmHg |
| Patients Achieving Diastolic Blood Pressure Control at Week 8 | week 8 | DBP \< 90 mmHg |
| Patients Achieving Blood Pressure Control at Week 4 | week 4 | SBP \< 140 mmHg and DBP \< 90 mmHg |
| Patients Achieving Blood Pressure Control at Week 6 | week 6 | SBP \< 140 mmHg and DBP \< 90 mmHg |
| Patients Achieving Blood Pressure Control at Week 8 | week 8 | SBP \< 140 mmHg and DBP \< 90 mmHg |
| Patients Achieving Diastolic Blood Pressure Response at Week 4 | baseline, week 4 | DBP \< 90 mmHg or reduction of \>= 10 mmHg |
| Patients Achieving Diastolic Blood Pressure Response at Week 6 | baseline, week 6 | DBP \< 90 mmHg or reduction of \>= 10 mmHg |
| Patients Achieving Diastolic Blood Pressure Response at Week 8 | baseline, week 8 | DBP \< 90 mmHg or reduction of \>= 10 mmHg |
| Patients Achieving Systolic Blood Pressure Response at Week 4 | baseline, week 4 | SBP \< 140 mmHg or reduction of \>= 15 mmHg |
| Patients Achieving Systolic Blood Pressure Response at Week 6 | baseline, week 6 | SBP \< 140 mmHg or reduction of \>= 15 mmHg |
| Patients Achieving Systolic Blood Pressure Response at Week 8 | baseline, week 8 | SBP \< 140 mmHg or reduction of \>= 15 mmHg |
| Patients Achieving Normal Blood Pressure Response at Week 4 | week 4 | Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90 |
| Patients Achieving Normal Blood Pressure Response at Week 6 | week 6 | Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90 |
| Patients Achieving Normal Blood Pressure Response at Week 8 | week 8 | Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90 |
| Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 | week 1 | Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90 |
Countries
Bulgaria, Czechia, France, Hungary, Romania, Russia, Slovakia, South Korea, Spain, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T80+A10 Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10) | 421 |
| Telmisartan 80 mg Telmisartan 80 mg once daily (T80) | 217 |
| Amlodipine 10 mg Amlodipine 10 mg once daily (A10) | 220 |
| Total | 858 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 9 | 6 | 7 |
| Overall Study | Lack of Efficacy | 0 | 4 | 3 |
| Overall Study | Lost to Follow-up | 2 | 0 | 1 |
| Overall Study | Other | 5 | 3 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 8 | 6 |
Baseline characteristics
| Characteristic | T80+A10 | Telmisartan 80 mg | Amlodipine 10 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 10.4 | 58.1 years STANDARD_DEVIATION 10.2 | 58.6 years STANDARD_DEVIATION 10.5 | 58.2 years STANDARD_DEVIATION 10.3 |
| Age, Customized < 65 years | 309 Participants | 158 Participants | 156 Participants | 623 Participants |
| Age, Customized >= 65 years | 112 Participants | 59 Participants | 64 Participants | 235 Participants |
| Body Mass Index (BMI) | 30.6 kilograms/square meter STANDARD_DEVIATION 5.9 | 30.2 kilograms/square meter STANDARD_DEVIATION 5.2 | 30.7 kilograms/square meter STANDARD_DEVIATION 6.3 | 30.6 kilograms/square meter STANDARD_DEVIATION 5.8 |
| Body Mass Index Class 25 <= BMI < 30 | 160 participants | 79 participants | 82 participants | 321 participants |
| Body Mass Index Class BMI < 25 | 63 participants | 31 participants | 35 participants | 129 participants |
| Body Mass Index Class BMI >= 30 | 198 participants | 107 participants | 103 participants | 408 participants |
| Duration of Hypertension | 10.3 years STANDARD_DEVIATION 9.6 | 9.4 years STANDARD_DEVIATION 9.2 | 10.3 years STANDARD_DEVIATION 10.1 | 10.1 years STANDARD_DEVIATION 9.6 |
| Duration of Hypertension Class > 10 years | 156 participants | 67 participants | 74 participants | 297 participants |
| Duration of Hypertension Class 1 - 5 years | 124 participants | 64 participants | 72 participants | 260 participants |
| Duration of Hypertension Class < 1 year | 38 participants | 25 participants | 20 participants | 83 participants |
| Duration of Hypertension Class 6 - 10 years | 103 participants | 61 participants | 54 participants | 218 participants |
| Number of previous antihypertensive treatments 0 | 49 participants | 37 participants | 26 participants | 112 participants |
| Number of previous antihypertensive treatments 1 | 133 participants | 67 participants | 78 participants | 278 participants |
| Number of previous antihypertensive treatments 2 | 136 participants | 59 participants | 71 participants | 266 participants |
| Number of previous antihypertensive treatments >= 3 | 103 participants | 54 participants | 45 participants | 202 participants |
| Race Class Black | 34 participants | 15 participants | 15 participants | 64 participants |
| Race Class Non-Black | 387 participants | 202 participants | 205 participants | 794 participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 5 participants | 1 participants | 0 participants | 6 participants |
| Race/Ethnicity, Customized Asian | 20 participants | 14 participants | 14 participants | 48 participants |
| Race/Ethnicity, Customized Black/African American | 34 participants | 15 participants | 15 participants | 64 participants |
| Race/Ethnicity, Customized Hawaiian/Pacific Islander | 0 participants | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized White | 362 participants | 186 participants | 190 participants | 738 participants |
| Sex: Female, Male Female | 202 Participants | 109 Participants | 102 Participants | 413 Participants |
| Sex: Female, Male Male | 219 Participants | 108 Participants | 118 Participants | 445 Participants |
| Type II Diabetes No | 349 participants | 183 participants | 197 participants | 729 participants |
| Type II Diabetes Yes | 72 participants | 34 participants | 23 participants | 129 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 67 / 421 | 25 / 217 | 42 / 220 |
| serious Total, serious adverse events | 3 / 421 | 2 / 217 | 2 / 220 |
Outcome results
Primary
Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8
Overall mean reduction from a common mean baseline in SBP
Time frame: baseline and week 8
Population: Full analysis set (FAS) included all randomised patients who had at least one seated trough cuff SBP following administration of study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T80+A10 | Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 | -47.5 mmHg (millimeters of mercury) | Standard Error 0.69 |
| Telmisartan 80 mg | Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 | -36.9 mmHg (millimeters of mercury) | Standard Error 0.96 |
| Amlodipine 10 mg | Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 | -43.2 mmHg (millimeters of mercury) | Standard Error 0.95 |
p-value: <0.000195% CI: [-12.9, -8.3]Repeated measures ANCOVA
p-value: 0.000295% CI: [-6.7, -2.1]Repeated measures ANCOVA
Secondary
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1
Overall mean reduction from a common mean baseline in DBP
Time frame: baseline and week 1
Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T80+A10 | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1 | -10.9 mmHg (millimeters of mercury) | Standard Error 0.37 |
| Telmisartan 80 mg | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1 | -8.2 mmHg (millimeters of mercury) | Standard Error 0.5 |
| Amlodipine 10 mg | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1 | -9.6 mmHg (millimeters of mercury) | Standard Error 0.5 |
Secondary
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2
Overall mean reduction from a common mean baseline in DBP
Time frame: baseline and week 2
Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T80+A10 | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2 | -13.2 mmHg (millimeters of mercury) | Standard Error 0.4 |
| Telmisartan 80 mg | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2 | -10.4 mmHg (millimeters of mercury) | Standard Error 0.56 |
| Amlodipine 10 mg | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2 | -11.4 mmHg (millimeters of mercury) | Standard Error 0.56 |
Secondary
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4
Overall mean reduction from a common mean baseline in DBP
Time frame: baseline and week 4
Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T80+A10 | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4 | -17.0 mmHg (millimeters of mercury) | Standard Error 0.43 |
| Telmisartan 80 mg | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4 | -12.1 mmHg (millimeters of mercury) | Standard Error 0.6 |
| Amlodipine 10 mg | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4 | -14.2 mmHg (millimeters of mercury) | Standard Error 0.6 |
Secondary
Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6
Overall mean reduction from a common mean baseline in DBP
Time frame: baseline and week 6
Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T80+A10 | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6 | -18.3 mmHg (millimeters of mercury) | Standard Error 0.41 |
| Telmisartan 80 mg | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6 | -13.5 mmHg (millimeters of mercury) | Standard Error 0.57 |
| Amlodipine 10 mg | Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6 | -15.7 mmHg (millimeters of mercury) | Standard Error 0.57 |
Secondary
Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8
Overall mean reduction from a common mean baseline in DBP
Time frame: baseline and week 8
Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T80+A10 | Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8 | -18.7 mmHg (millimeters of mercury) | Standard Error 0.41 |
| Telmisartan 80 mg | Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8 | -13.8 mmHg (millimeters of mercury) | Standard Error 0.58 |
| Amlodipine 10 mg | Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8 | -16.3 mmHg (millimeters of mercury) | Standard Error 0.58 |
Secondary
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1
Overall mean reduction from a common mean baseline in SBP
Time frame: baseline and week 1
Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T80+A10 | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1 | -31.9 mmHg (millimeters of mercury) | Standard Error 0.72 |
| Telmisartan 80 mg | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1 | -25.4 mmHg (millimeters of mercury) | Standard Error 0.99 |
| Amlodipine 10 mg | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1 | -28.6 mmHg (millimeters of mercury) | Standard Error 0.99 |
p-value: <0.000195% CI: [-8.8, -4]Repeated measures ANCOVA
p-value: 0.007795% CI: [-5.7, -0.9]Repeated measures ANCOVA
Secondary
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2
Overall mean reduction from a common mean baseline in SBP
Time frame: baseline and week 2
Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T80+A10 | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2 | -37.9 mmHg (millimeters of mercury) | Standard Error 0.71 |
| Telmisartan 80 mg | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2 | -30.1 mmHg (millimeters of mercury) | Standard Error 0.97 |
| Amlodipine 10 mg | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2 | -33.3 mmHg (millimeters of mercury) | Standard Error 0.98 |
p-value: <0.000195% CI: [-10.2, -5.4]Repeated measures ANCOVA
p-value: 0.000195% CI: [-7, -2.3]Repeated measures ANCOVA
Secondary
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4
Overall mean reduction from a common mean baseline in SBP
Time frame: baseline and week 4
Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T80+A10 | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 | -44.5 mmHg (millimeters of mercury) | Standard Error 0.73 |
| Telmisartan 80 mg | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 | -34.4 mmHg (millimeters of mercury) | Standard Error 1.01 |
| Amlodipine 10 mg | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 | -39.8 mmHg (millimeters of mercury) | Standard Error 1.01 |
p-value: <0.000195% CI: [-12.6, -7.7]Repeated measures ANCOVA
p-value: 0.000195% CI: [-7.2, -2.4]Repeated measures ANCOVA
Secondary
Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6
Overall mean reduction from a common mean baseline in SBP
Time frame: baseline and week 6
Population: Full analysis set (FAS) included all patients who had efficacy data consisting of a baseline and at least one post-baseline trough BP measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| T80+A10 | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 | -46.9 mmHg (millimeters of mercury) | Standard Error 0.73 |
| Telmisartan 80 mg | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 | -36.3 mmHg (millimeters of mercury) | Standard Error 1.01 |
| Amlodipine 10 mg | Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 | -42.1 mmHg (millimeters of mercury) | Standard Error 1.01 |
p-value: <0.000195% CI: [-13.1, -8.2]Repeated measures ANCOVA
p-value: 0.000195% CI: [-7.3, -2.4]Repeated measures ANCOVA
Secondary
Number of Patients Achieving Various Blood Pressure Response Levels at Week 1
Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90
Time frame: week 1
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 | Optimal | 3 participants |
| T80+A10 | Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 | Normal | 9 participants |
| T80+A10 | Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 | High Normal | 42 participants |
| T80+A10 | Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 | High | 333 participants |
| Telmisartan 80 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 | High | 191 participants |
| Telmisartan 80 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 | Optimal | 0 participants |
| Telmisartan 80 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 | High Normal | 13 participants |
| Telmisartan 80 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 | Normal | 3 participants |
| Amlodipine 10 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 | High | 192 participants |
| Amlodipine 10 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 | Normal | 3 participants |
| Amlodipine 10 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 | High Normal | 12 participants |
| Amlodipine 10 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 | Optimal | 0 participants |
Secondary
Number of Patients Achieving Various Blood Pressure Response Levels at Week 2
Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90
Time frame: week 2
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 | Optimal | 6 participants |
| T80+A10 | Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 | Normal | 21 participants |
| T80+A10 | Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 | High Normal | 61 participants |
| T80+A10 | Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 | High | 317 participants |
| Telmisartan 80 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 | High | 182 participants |
| Telmisartan 80 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 | Optimal | 0 participants |
| Telmisartan 80 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 | High Normal | 23 participants |
| Telmisartan 80 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 | Normal | 7 participants |
| Amlodipine 10 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 | High | 184 participants |
| Amlodipine 10 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 | Normal | 5 participants |
| Amlodipine 10 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 | High Normal | 23 participants |
| Amlodipine 10 mg | Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 | Optimal | 0 participants |
Secondary
Patients Achieving Blood Pressure Control at Week 1
Blood Pressure Control is defined as achieving SBP\< 140 mmHg and DBP \< 90mmHg
Time frame: week 1
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Blood Pressure Control at Week 1 | Controlled | 54 participants |
| T80+A10 | Patients Achieving Blood Pressure Control at Week 1 | Not Controlled | 333 participants |
| Telmisartan 80 mg | Patients Achieving Blood Pressure Control at Week 1 | Controlled | 16 participants |
| Telmisartan 80 mg | Patients Achieving Blood Pressure Control at Week 1 | Not Controlled | 191 participants |
| Amlodipine 10 mg | Patients Achieving Blood Pressure Control at Week 1 | Controlled | 15 participants |
| Amlodipine 10 mg | Patients Achieving Blood Pressure Control at Week 1 | Not Controlled | 192 participants |
Secondary
Patients Achieving Blood Pressure Control at Week 2
SBP \< 140 mmHg and DBP \< 90 mmHg
Time frame: week 2
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Blood Pressure Control at Week 2 | Controlled | 88 participants |
| T80+A10 | Patients Achieving Blood Pressure Control at Week 2 | Not Controlled | 317 participants |
| Telmisartan 80 mg | Patients Achieving Blood Pressure Control at Week 2 | Controlled | 30 participants |
| Telmisartan 80 mg | Patients Achieving Blood Pressure Control at Week 2 | Not Controlled | 182 participants |
| Amlodipine 10 mg | Patients Achieving Blood Pressure Control at Week 2 | Controlled | 28 participants |
| Amlodipine 10 mg | Patients Achieving Blood Pressure Control at Week 2 | Not Controlled | 184 participants |
Secondary
Patients Achieving Blood Pressure Control at Week 4
SBP \< 140 mmHg and DBP \< 90 mmHg
Time frame: week 4
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Blood Pressure Control at Week 4 | Controlled | 161 participants |
| T80+A10 | Patients Achieving Blood Pressure Control at Week 4 | Not Controlled | 231 participants |
| Telmisartan 80 mg | Patients Achieving Blood Pressure Control at Week 4 | Controlled | 49 participants |
| Telmisartan 80 mg | Patients Achieving Blood Pressure Control at Week 4 | Not Controlled | 163 participants |
| Amlodipine 10 mg | Patients Achieving Blood Pressure Control at Week 4 | Controlled | 53 participants |
| Amlodipine 10 mg | Patients Achieving Blood Pressure Control at Week 4 | Not Controlled | 150 participants |
Secondary
Patients Achieving Blood Pressure Control at Week 6
SBP \< 140 mmHg and DBP \< 90 mmHg
Time frame: week 6
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Blood Pressure Control at Week 6 | Controlled | 196 participants |
| T80+A10 | Patients Achieving Blood Pressure Control at Week 6 | Not Controlled | 198 participants |
| Telmisartan 80 mg | Patients Achieving Blood Pressure Control at Week 6 | Controlled | 54 participants |
| Telmisartan 80 mg | Patients Achieving Blood Pressure Control at Week 6 | Not Controlled | 158 participants |
| Amlodipine 10 mg | Patients Achieving Blood Pressure Control at Week 6 | Controlled | 77 participants |
| Amlodipine 10 mg | Patients Achieving Blood Pressure Control at Week 6 | Not Controlled | 128 participants |
Secondary
Patients Achieving Blood Pressure Control at Week 8
SBP \< 140 mmHg and DBP \< 90 mmHg
Time frame: week 8
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Blood Pressure Control at Week 8 | Controlled | 199 participants |
| T80+A10 | Patients Achieving Blood Pressure Control at Week 8 | Not Controlled | 196 participants |
| Telmisartan 80 mg | Patients Achieving Blood Pressure Control at Week 8 | Controlled | 51 participants |
| Telmisartan 80 mg | Patients Achieving Blood Pressure Control at Week 8 | Not Controlled | 161 participants |
| Amlodipine 10 mg | Patients Achieving Blood Pressure Control at Week 8 | Controlled | 73 participants |
| Amlodipine 10 mg | Patients Achieving Blood Pressure Control at Week 8 | Not Controlled | 132 participants |
Secondary
Patients Achieving Diastolic Blood Pressure Control at Week 1
Diastolic Blood Pressure Control is defined as achieving DBP \< 90mmHg
Time frame: week 1
Population: Full analysis set, imputation method used was last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Diastolic Blood Pressure Control at Week 1 | Controlled | 147 participants |
| T80+A10 | Patients Achieving Diastolic Blood Pressure Control at Week 1 | Not Controlled | 240 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Control at Week 1 | Controlled | 61 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Control at Week 1 | Not Controlled | 146 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Control at Week 1 | Controlled | 64 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Control at Week 1 | Not Controlled | 143 participants |
Secondary
Patients Achieving Diastolic Blood Pressure Control at Week 2
DBP \< 90 mmHg
Time frame: week 2
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Diastolic Blood Pressure Control at Week 2 | Controlled | 205 participants |
| T80+A10 | Patients Achieving Diastolic Blood Pressure Control at Week 2 | Not Controlled | 200 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Control at Week 2 | Controlled | 87 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Control at Week 2 | Not Controlled | 125 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Control at Week 2 | Controlled | 91 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Control at Week 2 | Not Controlled | 121 participants |
Secondary
Patients Achieving Diastolic Blood Pressure Control at Week 4
DBP \< 90 mmHg
Time frame: week 4
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Diastolic Blood Pressure Control at Week 4 | Controlled | 268 participants |
| T80+A10 | Patients Achieving Diastolic Blood Pressure Control at Week 4 | Not Controlled | 124 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Control at Week 4 | Controlled | 106 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Control at Week 4 | Not Controlled | 106 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Control at Week 4 | Controlled | 109 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Control at Week 4 | Not Controlled | 94 participants |
Secondary
Patients Achieving Diastolic Blood Pressure Control at Week 6
DBP \< 90 mmHg
Time frame: week 6
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Diastolic Blood Pressure Control at Week 6 | Controlled | 290 participants |
| T80+A10 | Patients Achieving Diastolic Blood Pressure Control at Week 6 | Not Controlled | 104 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Control at Week 6 | Controlled | 110 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Control at Week 6 | Not Controlled | 102 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Control at Week 6 | Controlled | 128 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Control at Week 6 | Not Controlled | 77 participants |
Secondary
Patients Achieving Diastolic Blood Pressure Control at Week 8
DBP \< 90 mmHg
Time frame: week 8
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Diastolic Blood Pressure Control at Week 8 | Controlled | 291 participants |
| T80+A10 | Patients Achieving Diastolic Blood Pressure Control at Week 8 | Not Controlled | 103 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Control at Week 8 | Controlled | 112 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Control at Week 8 | Not Controlled | 100 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Control at Week 8 | Controlled | 131 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Control at Week 8 | Not Controlled | 74 participants |
Secondary
Patients Achieving Diastolic Blood Pressure Response at Week 1
Diastolic Blood Pressure Response is defined as achieving DBP \< 90 mmHg or a reduction of \>= 10 mmHg
Time frame: baseline, week 1
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Diastolic Blood Pressure Response at Week 1 | Controlled | 232 participants |
| T80+A10 | Patients Achieving Diastolic Blood Pressure Response at Week 1 | Not Controlled | 155 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Response at Week 1 | Controlled | 95 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Response at Week 1 | Not Controlled | 112 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Response at Week 1 | Controlled | 100 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Response at Week 1 | Not Controlled | 107 participants |
Secondary
Patients Achieving Diastolic Blood Pressure Response at Week 2
DBP \< 90 mmHg or reduction of \>= 10 mmHg
Time frame: baseline, week 2
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Diastolic Blood Pressure Response at Week 2 | Controlled | 289 participants |
| T80+A10 | Patients Achieving Diastolic Blood Pressure Response at Week 2 | Not Controlled | 116 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Response at Week 2 | Controlled | 123 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Response at Week 2 | Not Controlled | 89 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Response at Week 2 | Controlled | 128 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Response at Week 2 | Not Controlled | 84 participants |
Secondary
Patients Achieving Diastolic Blood Pressure Response at Week 4
DBP \< 90 mmHg or reduction of \>= 10 mmHg
Time frame: baseline, week 4
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Diastolic Blood Pressure Response at Week 4 | Controlled | 339 participants |
| T80+A10 | Patients Achieving Diastolic Blood Pressure Response at Week 4 | Not Controlled | 53 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Response at Week 4 | Controlled | 132 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Response at Week 4 | Not Controlled | 80 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Response at Week 4 | Controlled | 151 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Response at Week 4 | Not Controlled | 61 participants |
Secondary
Patients Achieving Diastolic Blood Pressure Response at Week 6
DBP \< 90 mmHg or reduction of \>= 10 mmHg
Time frame: baseline, week 6
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Diastolic Blood Pressure Response at Week 6 | Controlled | 356 participants |
| T80+A10 | Patients Achieving Diastolic Blood Pressure Response at Week 6 | Not Controlled | 38 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Response at Week 6 | Controlled | 144 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Response at Week 6 | Not Controlled | 68 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Response at Week 6 | Controlled | 168 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Response at Week 6 | Not Controlled | 37 participants |
Secondary
Patients Achieving Diastolic Blood Pressure Response at Week 8
DBP \< 90 mmHg or reduction of \>= 10 mmHg
Time frame: baseline, week 8
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Diastolic Blood Pressure Response at Week 8 | Controlled | 361 participants |
| T80+A10 | Patients Achieving Diastolic Blood Pressure Response at Week 8 | Not Controlled | 34 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Response at Week 8 | Controlled | 147 participants |
| Telmisartan 80 mg | Patients Achieving Diastolic Blood Pressure Response at Week 8 | Not Controlled | 65 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Response at Week 8 | Controlled | 172 participants |
| Amlodipine 10 mg | Patients Achieving Diastolic Blood Pressure Response at Week 8 | Not Controlled | 33 participants |
Secondary
Patients Achieving Normal Blood Pressure Response at Week 4
Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90
Time frame: week 4
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Normal Blood Pressure Response at Week 4 | Optimal | 15 participants |
| T80+A10 | Patients Achieving Normal Blood Pressure Response at Week 4 | Normal | 47 participants |
| T80+A10 | Patients Achieving Normal Blood Pressure Response at Week 4 | High Normal | 99 participants |
| T80+A10 | Patients Achieving Normal Blood Pressure Response at Week 4 | High | 231 participants |
| Telmisartan 80 mg | Patients Achieving Normal Blood Pressure Response at Week 4 | High | 163 participants |
| Telmisartan 80 mg | Patients Achieving Normal Blood Pressure Response at Week 4 | Optimal | 4 participants |
| Telmisartan 80 mg | Patients Achieving Normal Blood Pressure Response at Week 4 | High Normal | 30 participants |
| Telmisartan 80 mg | Patients Achieving Normal Blood Pressure Response at Week 4 | Normal | 15 participants |
| Amlodipine 10 mg | Patients Achieving Normal Blood Pressure Response at Week 4 | High | 150 participants |
| Amlodipine 10 mg | Patients Achieving Normal Blood Pressure Response at Week 4 | Normal | 14 participants |
| Amlodipine 10 mg | Patients Achieving Normal Blood Pressure Response at Week 4 | High Normal | 37 participants |
| Amlodipine 10 mg | Patients Achieving Normal Blood Pressure Response at Week 4 | Optimal | 2 participants |
Secondary
Patients Achieving Normal Blood Pressure Response at Week 6
Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90
Time frame: week 6
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Normal Blood Pressure Response at Week 6 | Optimal | 17 participants |
| T80+A10 | Patients Achieving Normal Blood Pressure Response at Week 6 | Normal | 73 participants |
| T80+A10 | Patients Achieving Normal Blood Pressure Response at Week 6 | High Normal | 106 participants |
| T80+A10 | Patients Achieving Normal Blood Pressure Response at Week 6 | High | 198 participants |
| Telmisartan 80 mg | Patients Achieving Normal Blood Pressure Response at Week 6 | High | 158 participants |
| Telmisartan 80 mg | Patients Achieving Normal Blood Pressure Response at Week 6 | Optimal | 5 participants |
| Telmisartan 80 mg | Patients Achieving Normal Blood Pressure Response at Week 6 | High Normal | 30 participants |
| Telmisartan 80 mg | Patients Achieving Normal Blood Pressure Response at Week 6 | Normal | 19 participants |
| Amlodipine 10 mg | Patients Achieving Normal Blood Pressure Response at Week 6 | High | 128 participants |
| Amlodipine 10 mg | Patients Achieving Normal Blood Pressure Response at Week 6 | Normal | 18 participants |
| Amlodipine 10 mg | Patients Achieving Normal Blood Pressure Response at Week 6 | High Normal | 56 participants |
| Amlodipine 10 mg | Patients Achieving Normal Blood Pressure Response at Week 6 | Optimal | 3 participants |
Secondary
Patients Achieving Normal Blood Pressure Response at Week 8
Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90
Time frame: week 8
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Normal Blood Pressure Response at Week 8 | Optimal | 18 participants |
| T80+A10 | Patients Achieving Normal Blood Pressure Response at Week 8 | Normal | 76 participants |
| T80+A10 | Patients Achieving Normal Blood Pressure Response at Week 8 | High Normal | 105 participants |
| T80+A10 | Patients Achieving Normal Blood Pressure Response at Week 8 | High | 196 participants |
| Telmisartan 80 mg | Patients Achieving Normal Blood Pressure Response at Week 8 | High | 161 participants |
| Telmisartan 80 mg | Patients Achieving Normal Blood Pressure Response at Week 8 | Optimal | 3 participants |
| Telmisartan 80 mg | Patients Achieving Normal Blood Pressure Response at Week 8 | High Normal | 27 participants |
| Telmisartan 80 mg | Patients Achieving Normal Blood Pressure Response at Week 8 | Normal | 21 participants |
| Amlodipine 10 mg | Patients Achieving Normal Blood Pressure Response at Week 8 | High | 132 participants |
| Amlodipine 10 mg | Patients Achieving Normal Blood Pressure Response at Week 8 | Normal | 25 participants |
| Amlodipine 10 mg | Patients Achieving Normal Blood Pressure Response at Week 8 | High Normal | 46 participants |
| Amlodipine 10 mg | Patients Achieving Normal Blood Pressure Response at Week 8 | Optimal | 2 participants |
Secondary
Patients Achieving Systolic Blood Pressure Response at Week 1
Systolic Blood Pressure Response Control is defined as achieving SBP \< 140 mmHg or a reduction of \>= 15 mmHg
Time frame: baseline, week 1
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Systolic Blood Pressure Response at Week 1 | Controlled | 338 participants |
| T80+A10 | Patients Achieving Systolic Blood Pressure Response at Week 1 | Not Controlled | 49 participants |
| Telmisartan 80 mg | Patients Achieving Systolic Blood Pressure Response at Week 1 | Controlled | 164 participants |
| Telmisartan 80 mg | Patients Achieving Systolic Blood Pressure Response at Week 1 | Not Controlled | 43 participants |
| Amlodipine 10 mg | Patients Achieving Systolic Blood Pressure Response at Week 1 | Controlled | 173 participants |
| Amlodipine 10 mg | Patients Achieving Systolic Blood Pressure Response at Week 1 | Not Controlled | 34 participants |
Secondary
Patients Achieving Systolic Blood Pressure Response at Week 2
SBP \< 140 mmHg or reduction of \>= 15 mmHg
Time frame: baseline, week 2
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Systolic Blood Pressure Response at Week 2 | Controlled | 387 participants |
| T80+A10 | Patients Achieving Systolic Blood Pressure Response at Week 2 | Not Controlled | 18 participants |
| Telmisartan 80 mg | Patients Achieving Systolic Blood Pressure Response at Week 2 | Controlled | 169 participants |
| Telmisartan 80 mg | Patients Achieving Systolic Blood Pressure Response at Week 2 | Not Controlled | 43 participants |
| Amlodipine 10 mg | Patients Achieving Systolic Blood Pressure Response at Week 2 | Controlled | 189 participants |
| Amlodipine 10 mg | Patients Achieving Systolic Blood Pressure Response at Week 2 | Not Controlled | 23 participants |
Secondary
Patients Achieving Systolic Blood Pressure Response at Week 4
SBP \< 140 mmHg or reduction of \>= 15 mmHg
Time frame: baseline, week 4
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Systolic Blood Pressure Response at Week 4 | Controlled | 388 participants |
| T80+A10 | Patients Achieving Systolic Blood Pressure Response at Week 4 | Not Controlled | 4 participants |
| Telmisartan 80 mg | Patients Achieving Systolic Blood Pressure Response at Week 4 | Controlled | 180 participants |
| Telmisartan 80 mg | Patients Achieving Systolic Blood Pressure Response at Week 4 | Not Controlled | 32 participants |
| Amlodipine 10 mg | Patients Achieving Systolic Blood Pressure Response at Week 4 | Controlled | 194 participants |
| Amlodipine 10 mg | Patients Achieving Systolic Blood Pressure Response at Week 4 | Not Controlled | 9 participants |
Secondary
Patients Achieving Systolic Blood Pressure Response at Week 6
SBP \< 140 mmHg or reduction of \>= 15 mmHg
Time frame: baseline, week 6
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Systolic Blood Pressure Response at Week 6 | Controlled | 388 participants |
| T80+A10 | Patients Achieving Systolic Blood Pressure Response at Week 6 | Not Controlled | 6 participants |
| Telmisartan 80 mg | Patients Achieving Systolic Blood Pressure Response at Week 6 | Controlled | 184 participants |
| Telmisartan 80 mg | Patients Achieving Systolic Blood Pressure Response at Week 6 | Not Controlled | 28 participants |
| Amlodipine 10 mg | Patients Achieving Systolic Blood Pressure Response at Week 6 | Controlled | 201 participants |
| Amlodipine 10 mg | Patients Achieving Systolic Blood Pressure Response at Week 6 | Not Controlled | 4 participants |
Secondary
Patients Achieving Systolic Blood Pressure Response at Week 8
SBP \< 140 mmHg or reduction of \>= 15 mmHg
Time frame: baseline, week 8
Population: FAS (LOCF)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T80+A10 | Patients Achieving Systolic Blood Pressure Response at Week 8 | Controlled | 391 participants |
| T80+A10 | Patients Achieving Systolic Blood Pressure Response at Week 8 | Not Controlled | 4 participants |
| Telmisartan 80 mg | Patients Achieving Systolic Blood Pressure Response at Week 8 | Controlled | 188 participants |
| Telmisartan 80 mg | Patients Achieving Systolic Blood Pressure Response at Week 8 | Not Controlled | 24 participants |
| Amlodipine 10 mg | Patients Achieving Systolic Blood Pressure Response at Week 8 | Controlled | 202 participants |
| Amlodipine 10 mg | Patients Achieving Systolic Blood Pressure Response at Week 8 | Not Controlled | 3 participants |