Hypertension
Conditions
Brief summary
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.
Interventions
DRUGtelmisartan/amlodipine 40/5 mg fixed combination
DRUGtelmisartan/amlodipine 80/5 mg fixed combination
Sponsors
Boehringer Ingelheim
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. patients aged at least 18 years 2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial. 3. failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of the preceding trial.
Exclusion criteria
1. pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study 2. development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either Telmisartan 40 mg/Amlodipine 5 mg or Telmisartan 80 mg/Amlodipine 5 mg 3. discontinuation from the preceding trial because of any adverse event or any other reason 4. known or suspected secondary hypertension 5. mean seated Systolic Blood Pressure =\> 180 mmHg and/or mean seated Diastolic Blood Pressure =\> 120 mmHg at any visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trough Seated Diastolic Blood Pressure (DBP) Control | End of study (34 weeks or last value on treatment) | The number of patients who reach the target DBP of \<90mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough Seated Diastolic Blood Pressure | End of study (34 weeks or last value on treatment) | Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5. |
| Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | End of study (34 weeks or last value on treatment) | The difference between the last available troughs represents the additional reduction in DBP in this study |
| Change From Baseline in Trough Seated Systolic Blood Pressure | End of study (34 weeks or last value on treatment) | Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5. |
| Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | End of study (34 weeks or last value on treatment) | The difference between the last available troughs represents the additional reduction in SBP in this study |
| Trough Seated DBP Response | End of study (34 weeks or last value on treatment) | The number of patients who reach the target DBP of \<90mmHg or had a reduction in DBP \>= 10mmHg |
| Trough Seated SBP Response | End of study (34 weeks or last value on treatment) | The number of patients who reach the target SBP of \<140mmHg or had a reduction in SBP \>= 15 mmHg |
| Trough Seated Systolic Blood Pressure (SBP) Control | End of study (34 weeks or last value on treatment) | The number of patients who reach the target SBP of \<140mmHg |
| Time to First Additional Antihypertensive | At any point during open-label treatment | Time from first intake of medication to first intake of an antihypertensive other than the study drug |
| Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | At any point during open-label treatment | The number of patients with DBP control (DBP\<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment |
| Additional Reduction in DBP by Use of Additional Antihypertensive Therapy | At any point during open-label treatment | Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7 |
| Additional Reduction in SBP by Use of Additional Antihypertensive Therapy | At any point during open-label treatment | Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7 |
| Trough DBP Control Pre- and Post- Uptitration | At any point during open-label treatment | The number of patients with DBP control (DBP\<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration |
| Trough Blood Pressure (BP) Normality Classes | End of study (34 weeks or last value on treatment) | The number of patients who reach predefined BP categories |
Countries
Belgium, Canada, Denmark, Finland, France, Netherlands, Norway, Philippines, South Africa, South Korea, Sweden, Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telmisartan 40mg and Amlodipine 5mg | 564 |
| Telmisartan 80mg and Amlodipine 5mg | 206 |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | 25 |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | 181 |
| Total | 976 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 14 | 4 | 0 | 0 |
| Overall Study | Consent withdrawn | 3 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 6 | 1 | 0 | 0 |
| Overall Study | Non compliant with the protocol | 12 | 2 | 1 | 2 |
Baseline characteristics
| Characteristic | Telmisartan 40mg and Amlodipine 5mg | Telmisartan 80mg and Amlodipine 5mg | Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Total |
|---|---|---|---|---|---|
| Age, Continuous | 54.8 Years STANDARD_DEVIATION 10.9 | 52.9 Years STANDARD_DEVIATION 10.6 | 54.4 Years STANDARD_DEVIATION 10.8 | 52.4 Years STANDARD_DEVIATION 9.6 | 53.9 Years STANDARD_DEVIATION 10.6 |
| Sex: Female, Male Female | 240 Participants | 72 Participants | 8 Participants | 45 Participants | 365 Participants |
| Sex: Female, Male Male | 324 Participants | 134 Participants | 17 Participants | 136 Participants | 611 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 57 / 976 | 45 / 397 |
| serious Total, serious adverse events | 22 / 976 | 6 / 397 |
Outcome results
Primary
Trough Seated Diastolic Blood Pressure (DBP) Control
The number of patients who reach the target DBP of \<90mmHg
Time frame: End of study (34 weeks or last value on treatment)
Population: The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 5mg | Trough Seated Diastolic Blood Pressure (DBP) Control | Yes (DBP<90 mmHg) | 504 Participants |
| Telmisartan 40mg and Amlodipine 5mg | Trough Seated Diastolic Blood Pressure (DBP) Control | No (DBP>=90 mmHg) | 49 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough Seated Diastolic Blood Pressure (DBP) Control | No (DBP>=90 mmHg) | 46 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough Seated Diastolic Blood Pressure (DBP) Control | Yes (DBP<90 mmHg) | 160 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated Diastolic Blood Pressure (DBP) Control | Yes (DBP<90 mmHg) | 19 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated Diastolic Blood Pressure (DBP) Control | No (DBP>=90 mmHg) | 6 Participants |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated Diastolic Blood Pressure (DBP) Control | Yes (DBP<90 mmHg) | 84 Participants |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated Diastolic Blood Pressure (DBP) Control | No (DBP>=90 mmHg) | 97 Participants |
95% CI: [0.22, 0.53]Cochran-Mantel-Haenszel
95% CI: [0.12, 0.81]Cochran-Mantel-Haenszel
95% CI: [0.06, 0.13]Cochran-Mantel-Haenszel
95% CI: [0.34, 2.41]Cochran-Mantel-Haenszel
95% CI: [0.16, 0.39]Cochran-Mantel-Haenszel
95% CI: [0.1, 0.72]Cochran-Mantel-Haenszel
Secondary
Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7
Time frame: At any point during open-label treatment
Population: Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 5mg | Additional Reduction in DBP by Use of Additional Antihypertensive Therapy | -5.73 mmHg | Standard Deviation 7.65 |
Secondary
Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7
Time frame: At any point during open-label treatment
Population: Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 5mg | Additional Reduction in SBP by Use of Additional Antihypertensive Therapy | -7.53 mmHg | Standard Deviation 11.21 |
Secondary
Change From Baseline in Trough Seated Diastolic Blood Pressure
Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5.
Time frame: End of study (34 weeks or last value on treatment)
Population: All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 1235.5) and at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 5mg | Change From Baseline in Trough Seated Diastolic Blood Pressure | -14.18 mmHg | Standard Error 0.31 |
| Telmisartan 80mg and Amlodipine 5mg | Change From Baseline in Trough Seated Diastolic Blood Pressure | -12.64 mmHg | Standard Error 0.52 |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Change From Baseline in Trough Seated Diastolic Blood Pressure | -9.47 mmHg | Standard Error 1.51 |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Change From Baseline in Trough Seated Diastolic Blood Pressure | -10.17 mmHg | Standard Error 0.56 |
Secondary
Change From Baseline in Trough Seated Systolic Blood Pressure
Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5.
Time frame: End of study (34 weeks or last value on treatment)
Population: Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 5mg | Change From Baseline in Trough Seated Systolic Blood Pressure | -17.79 mmHg | Standard Error 0.52 |
| Telmisartan 80mg and Amlodipine 5mg | Change From Baseline in Trough Seated Systolic Blood Pressure | -15.91 mmHg | Standard Error 0.86 |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Change From Baseline in Trough Seated Systolic Blood Pressure | -12.6 mmHg | Standard Error 2.5 |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Change From Baseline in Trough Seated Systolic Blood Pressure | -14.04 mmHg | Standard Error 0.92 |
Secondary
Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
The difference between the last available troughs represents the additional reduction in DBP in this study
Time frame: End of study (34 weeks or last value on treatment)
Population: Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 5mg | Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | -3.54 mmHg | Standard Error 0.33 |
| Telmisartan 80mg and Amlodipine 5mg | Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | -5.52 mmHg | Standard Error 0.55 |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | -5.51 mmHg | Standard Error 1.59 |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | -5.74 mmHg | Standard Error 0.58 |
Secondary
Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
The difference between the last available troughs represents the additional reduction in SBP in this study
Time frame: End of study (34 weeks or last value on treatment)
Population: All patients who took at least one dose of study medication, have a trough baseline measurement (Last value on treatment in 1235.5) and at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 5mg | Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | -4.14 mmHg | Standard Error 0.5 |
| Telmisartan 80mg and Amlodipine 5mg | Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | -5.62 mmHg | Standard Error 0.83 |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | -3.6 mmHg | Standard Error 2.41 |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | -7.17 mmHg | Standard Error 0.88 |
Secondary
Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
The number of patients with DBP control (DBP\<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment
Time frame: At any point during open-label treatment
Population: Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 5mg | Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: No (DBP>=90 mmHg) | 2 Participants |
| Telmisartan 40mg and Amlodipine 5mg | Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: Yes (DBP<90 mmHg) | 10 Participants |
| Telmisartan 40mg and Amlodipine 5mg | Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: Total | 12 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: No (DBP>=90 mmHg) | 106 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: Yes (DBP<90 mmHg) | 100 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: Total | 206 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: Yes (DBP<90 mmHg) | 110 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: Total | 218 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: No (DBP>=90 mmHg) | 108 Participants |
Secondary
Time to First Additional Antihypertensive
Time from first intake of medication to first intake of an antihypertensive other than the study drug
Time frame: At any point during open-label treatment
Population: Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 5mg | Time to First Additional Antihypertensive | 85.8 Days | Standard Deviation 38.4 |
Secondary
Trough Blood Pressure (BP) Normality Classes
The number of patients who reach predefined BP categories
Time frame: End of study (34 weeks or last value on treatment)
Population: The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 5mg | Trough Blood Pressure (BP) Normality Classes | Optimal (SBP<120 and DBP<80 mmHg) | 67 Participants |
| Telmisartan 40mg and Amlodipine 5mg | Trough Blood Pressure (BP) Normality Classes | Normal (SBP<130 and DBP<85 mmHg and not optimal) | 188 Participants |
| Telmisartan 40mg and Amlodipine 5mg | Trough Blood Pressure (BP) Normality Classes | High-normal (SBP<140 DBP<90 mmHg and not normal) | 163 Participants |
| Telmisartan 40mg and Amlodipine 5mg | Trough Blood Pressure (BP) Normality Classes | Stage 1 hypertension (SBP<160 and DBP<100 mmHg | 122 Participants |
| Telmisartan 40mg and Amlodipine 5mg | Trough Blood Pressure (BP) Normality Classes | Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg) | 13 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough Blood Pressure (BP) Normality Classes | Optimal (SBP<120 and DBP<80 mmHg) | 4 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough Blood Pressure (BP) Normality Classes | Stage 1 hypertension (SBP<160 and DBP<100 mmHg | 73 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough Blood Pressure (BP) Normality Classes | Normal (SBP<130 and DBP<85 mmHg and not optimal) | 29 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough Blood Pressure (BP) Normality Classes | High-normal (SBP<140 DBP<90 mmHg and not normal) | 92 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough Blood Pressure (BP) Normality Classes | Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg) | 8 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough Blood Pressure (BP) Normality Classes | High-normal (SBP<140 DBP<90 mmHg and not normal) | 9 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough Blood Pressure (BP) Normality Classes | Stage 1 hypertension (SBP<160 and DBP<100 mmHg | 12 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough Blood Pressure (BP) Normality Classes | Optimal (SBP<120 and DBP<80 mmHg) | 1 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough Blood Pressure (BP) Normality Classes | Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg) | 0 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough Blood Pressure (BP) Normality Classes | Normal (SBP<130 and DBP<85 mmHg and not optimal) | 3 Participants |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Trough Blood Pressure (BP) Normality Classes | Stage 1 hypertension (SBP<160 and DBP<100 mmHg | 105 Participants |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Trough Blood Pressure (BP) Normality Classes | Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg) | 24 Participants |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Trough Blood Pressure (BP) Normality Classes | High-normal (SBP<140 DBP<90 mmHg and not normal) | 34 Participants |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Trough Blood Pressure (BP) Normality Classes | Normal (SBP<130 and DBP<85 mmHg and not optimal) | 12 Participants |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Trough Blood Pressure (BP) Normality Classes | Optimal (SBP<120 and DBP<80 mmHg) | 6 Participants |
Secondary
Trough DBP Control Pre- and Post- Uptitration
The number of patients with DBP control (DBP\<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration
Time frame: At any point during open-label treatment
Population: Patients from the full analysis set who up-titrated to the higher dose of telmisartan 80 mg and amlodipine 10 mg. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 5mg | Trough DBP Control Pre- and Post- Uptitration | Post-titration: No (DBP>=90 mmHg) | 0 Participants |
| Telmisartan 40mg and Amlodipine 5mg | Trough DBP Control Pre- and Post- Uptitration | Post-titration: Yes (DBP<90 mmHg) | 17 Participants |
| Telmisartan 40mg and Amlodipine 5mg | Trough DBP Control Pre- and Post- Uptitration | Post-titration: Total | 17 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough DBP Control Pre- and Post- Uptitration | Post-titration: No (DBP>=90 mmHg) | 171 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough DBP Control Pre- and Post- Uptitration | Post-titration: Total | 361 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough DBP Control Pre- and Post- Uptitration | Post-titration: Yes (DBP<90 mmHg) | 190 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough DBP Control Pre- and Post- Uptitration | Post-titration: No (DBP>=90 mmHg) | 171 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough DBP Control Pre- and Post- Uptitration | Post-titration: Yes (DBP<90 mmHg) | 207 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough DBP Control Pre- and Post- Uptitration | Post-titration: Total | 378 Participants |
Secondary
Trough Seated DBP Response
The number of patients who reach the target DBP of \<90mmHg or had a reduction in DBP \>= 10mmHg
Time frame: End of study (34 weeks or last value on treatment)
Population: The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 5mg | Trough Seated DBP Response | No (Non-responder) | 45 Participants |
| Telmisartan 40mg and Amlodipine 5mg | Trough Seated DBP Response | Yes (Responder) | 504 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough Seated DBP Response | No (Non-responder) | 32 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough Seated DBP Response | Yes (Responder) | 171 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated DBP Response | No (Non-responder) | 5 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated DBP Response | Yes (Responder) | 19 Participants |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated DBP Response | Yes (Responder) | 108 Participants |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated DBP Response | No (Non-responder) | 68 Participants |
Secondary
Trough Seated SBP Response
The number of patients who reach the target SBP of \<140mmHg or had a reduction in SBP \>= 15 mmHg
Time frame: End of study (34 weeks or last value on treatment)
Population: The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 5mg | Trough Seated SBP Response | Yes (Responder) | 490 Participants |
| Telmisartan 40mg and Amlodipine 5mg | Trough Seated SBP Response | No (Non-responder) | 59 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough Seated SBP Response | No (Non-responder) | 24 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough Seated SBP Response | Yes (Responder) | 179 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated SBP Response | Yes (Responder) | 18 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated SBP Response | No (Non-responder) | 6 Participants |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated SBP Response | No (Non-responder) | 48 Participants |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated SBP Response | Yes (Responder) | 128 Participants |
Secondary
Trough Seated Systolic Blood Pressure (SBP) Control
The number of patients who reach the target SBP of \<140mmHg
Time frame: End of study (34 weeks or last value on treatment)
Population: The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 5mg | Trough Seated Systolic Blood Pressure (SBP) Control | Yes (SBP<140 mmHg) | 440 Participants |
| Telmisartan 40mg and Amlodipine 5mg | Trough Seated Systolic Blood Pressure (SBP) Control | No (SBP>=140 mmHg) | 113 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough Seated Systolic Blood Pressure (SBP) Control | Yes (SBP<140 mmHg) | 142 Participants |
| Telmisartan 80mg and Amlodipine 5mg | Trough Seated Systolic Blood Pressure (SBP) Control | No (SBP>=140 mmHg) | 64 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated Systolic Blood Pressure (SBP) Control | No (SBP>=140 mmHg) | 9 Participants |
| Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated Systolic Blood Pressure (SBP) Control | Yes (SBP<140 mmHg) | 16 Participants |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated Systolic Blood Pressure (SBP) Control | No (SBP>=140 mmHg) | 92 Participants |
| Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive | Trough Seated Systolic Blood Pressure (SBP) Control | Yes (SBP<140 mmHg) | 89 Participants |