Hypertension
Conditions
Brief summary
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months. An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension. The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP \< 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).
Interventions
DRUGfixed-dose combination of telmisartan 40mg+amlodipine 10mg
DRUGfixed-dose combination of telmisartan 80mg+amlodipine10mg
Sponsors
Boehringer Ingelheim
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- diagnosis of essential hypertension
Exclusion criteria
* pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential). * development of any condition in the preceding trial that could be worsened by telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10). * discontinuation from the preceding trial. * known or suspected secondary hypertension. * mean seated systolic blood pressure (SBP) \>= 180 mmHg and/or mean seated diastolic blood pressure (DBP) \>= 120 mmHg at any visit. * any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant. * clinically relevant hyperkalaemia. * uncorrected volume or sodium depletion. * primary aldosteronism. * hereditary fructose or lactose intolerance. * symptomatic congestive heart failure. * patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). * any new drug or alcohol dependency since signing consent of the preceding trial. * concurrent participation in another clinical trial or any investigational therapy since completing the preceding trial. * hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve. * known allergic hypersensitivity to any component of the formulations under investigation. \[Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine calcium channel blockers (CCBs).\] non-compliance with study medication (defined as \<80% or \>120%) during the preceding trial. * administration of ARBs or dihydropyridine CCBs (apart from trial medication). any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.
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 reached the target DBP of \<90mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure | Baseline is defined as visit 3 of study NCT00553267 and end of study as 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 1235.6 |
| Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052 | Last available trough in NCT00553267 to 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 to End of Study in Trough Seated Systolic Blood Pressure | Baseline is defined as visit 3 of study NCT00553267 and end of study as 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 1235.6 |
| Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052 | Last available trough in NCT00624052 to 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 reached the target SBP of \>=140mmHg |
| Time to First Additional Antihypertensive | up to 34 weeks | Time from first intake of medication to first intake of an antihypertensive other than the study drug |
| Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | up to 34 weeks | 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 | up to 34 weeks | Difference in trough DBP from last visit before add-on therapy and last visit during NCT00624052 |
| Additional Reduction in SBP by Use of Additional Antihypertensive Therapy | up to 34 weeks | Difference in trough SBP from last visit before add-on therapy and last visit during NCT00624052 |
| Trough DBP Control Pre- and Post- Uptitration | up to 34 weeks | The number of patients with DBP control (DBP\<90 mmHg). Last trough DBP measurement before uptitration to telmisartan 80mg and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP\>90 or investigator opinion. |
| Trough BP Normality Classes | End of study (34 weeks or last value on treatment) | The number of patients who reach predefined BP categories |
Countries
Australia, Austria, Bulgaria, Czechia, Ireland, Italy, New Zealand, Russia, Slovakia, Spain, Ukraine, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telmisartan 40mg and Amlodipine 10mg | 219 |
| Randomised Telmisartan 80mg and Amlodipine 10mg | 436 |
| Titrated Telmisartan 80mg and Amlodipine 10mg | 91 |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | 92 |
| Total | 838 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 6 | 0 | 3 |
| Overall Study | Changed job/ran out if meds | 0 | 2 | 0 | 0 |
| Overall Study | Consent withdrawn | 3 | 1 | 1 | 0 |
| Overall Study | Lack of Efficacy | 1 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 3 | 1 | 0 |
| Overall Study | Non compliant with the protocol | 2 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Telmisartan 40mg and Amlodipine 10mg | Randomised Telmisartan 80mg and Amlodipine 10mg | Titrated Telmisartan 80mg and Amlodipine 10mg | Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Total |
|---|---|---|---|---|---|
| Age, Continuous | 56.2 Years STANDARD_DEVIATION 9.9 | 57.3 Years STANDARD_DEVIATION 9.4 | 55.2 Years STANDARD_DEVIATION 9.7 | 53.3 Years STANDARD_DEVIATION 10.3 | 56.4 Years STANDARD_DEVIATION 9.7 |
| Sex: Female, Male Female | 93 Participants | 206 Participants | 31 Participants | 37 Participants | 367 Participants |
| Sex: Female, Male Male | 126 Participants | 230 Participants | 60 Participants | 55 Participants | 471 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 838 | 0 / 611 |
| serious Total, serious adverse events | 4 / 838 | 13 / 611 |
Outcome results
Primary
Trough Seated Diastolic Blood Pressure (DBP) Control
The number of patients who reached 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 10mg | Trough Seated Diastolic Blood Pressure (DBP) Control | Yes (DBP<90 mmHg) | 201 patients |
| Telmisartan 40mg and Amlodipine 10mg | Trough Seated Diastolic Blood Pressure (DBP) Control | No (DBP>=90 mmHg) | 15 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough Seated Diastolic Blood Pressure (DBP) Control | Yes (DBP<90 mmHg) | 402 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough Seated Diastolic Blood Pressure (DBP) Control | No (DBP>=90 mmHg) | 34 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough Seated Diastolic Blood Pressure (DBP) Control | Yes (DBP<90 mmHg) | 72 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough Seated Diastolic Blood Pressure (DBP) Control | No (DBP>=90 mmHg) | 19 patients |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Trough Seated Diastolic Blood Pressure (DBP) Control | No (DBP>=90 mmHg) | 22 patients |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Trough Seated Diastolic Blood Pressure (DBP) Control | Yes (DBP<90 mmHg) | 70 patients |
95% CI: [0.14, 0.59]Cochran-Mantel-Haenszel
95% CI: [0.12, 0.48]Cochran-Mantel-Haenszel
95% CI: [0.17, 0.59]Cochran-Mantel-Haenszel
95% CI: [0.15, 0.49]Cochran-Mantel-Haenszel
95% CI: [0.47, 1.66]Cochran-Mantel-Haenszel
95% CI: [0.42, 1.68]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 NCT00624052
Time frame: up to 34 weeks
Population: Total for the full analysis set. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 10mg | Additional Reduction in DBP by Use of Additional Antihypertensive Therapy | -6.79 mmHg | Standard Deviation 7.39 |
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 NCT00624052
Time frame: up to 34 weeks
Population: Total for the full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 10mg | Additional Reduction in SBP by Use of Additional Antihypertensive Therapy | -7.79 mmHg | Standard Deviation 12.37 |
Secondary
Change From Baseline to End of Study 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 1235.6
Time frame: Baseline is defined as visit 3 of study NCT00553267 and end of study as 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 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 10mg | Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure | -13.41 mmHg | Standard Error 0.44 |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure | -13.36 mmHg | Standard Error 0.31 |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure | -11.52 mmHg | Standard Error 0.69 |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure | -10.64 mmHg | Standard Error 0.67 |
Secondary
Change From Baseline to End of Study 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 1235.6
Time frame: Baseline is defined as visit 3 of study NCT00553267 and end of study as 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 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 10mg | Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure | -14.76 mmHg | Standard Error 0.72 |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure | -15.93 mmHg | Standard Error 0.5 |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure | -14.85 mmHg | Standard Error 1.12 |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure | -12.44 mmHg | Standard Error 1.1 |
Secondary
Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
The difference between the last available troughs represents the additional reduction in DBP in this study
Time frame: Last available trough in NCT00553267 to 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 end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 10mg | Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052 | -4.36 mmHg | Standard Error 0.48 |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052 | -4.97 mmHg | Standard Error 0.34 |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052 | -5.51 mmHg | Standard Error 0.74 |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052 | -5.43 mmHg | Standard Error 0.73 |
Secondary
Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
The difference between the last available troughs represents the additional reduction in SBP in this study
Time frame: Last available trough in NCT00624052 to 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 end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 10mg | Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052 | -4.73 mmHg | Standard Error 0.73 |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052 | -6.02 mmHg | Standard Error 0.51 |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052 | -6.55 mmHg | Standard Error 1.11 |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052 | -5.61 mmHg | Standard Error 1.1 |
Secondary
Number of 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: up to 34 weeks
Population: Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 10mg | Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: Yes (DBP<90 mmHg) | 27 patients |
| Telmisartan 40mg and Amlodipine 10mg | Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: Total | 31 patients |
| Telmisartan 40mg and Amlodipine 10mg | Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: No (DBP>=90 mmHg) | 4 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: Yes (DBP<90 mmHg) | 67 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: No (DBP>=90 mmHg) | 23 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: Total | 90 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: Yes (DBP<90 mmHg) | 94 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: Total | 121 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | Post-antihypertensive: No (DBP>=90 mmHg) | 27 patients |
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: up to 34 weeks
Population: The total of the number of patients in the BP normality classes. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 10mg | Time to First Additional Antihypertensive | 91.9 Days | Standard Deviation 45.2 |
Secondary
Trough BP Normality Classes
The number of patients who reach predefined BP categories
Time frame: End of study (34 weeks or last value on treatment)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 10mg | Trough BP Normality Classes | Stage 1 hypertension (SBP<160 and DBP<100 mmHg | 32 patients |
| Telmisartan 40mg and Amlodipine 10mg | Trough BP Normality Classes | Normal (SBP<130 and DBP<85 mmHg and not optimal) | 70 patients |
| Telmisartan 40mg and Amlodipine 10mg | Trough BP Normality Classes | Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg) | 8 patients |
| Telmisartan 40mg and Amlodipine 10mg | Trough BP Normality Classes | High-normal (SBP<140 DBP<90 mmHg and not normal) | 94 patients |
| Telmisartan 40mg and Amlodipine 10mg | Trough BP Normality Classes | Optimal (SBP<120 and DBP<80 mmHg) | 12 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough BP Normality Classes | High-normal (SBP<140 DBP<90 mmHg and not normal) | 189 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough BP Normality Classes | Stage 1 hypertension (SBP<160 and DBP<100 mmHg | 76 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough BP Normality Classes | Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg) | 5 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough BP Normality Classes | Normal (SBP<130 and DBP<85 mmHg and not optimal) | 146 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough BP Normality Classes | Optimal (SBP<120 and DBP<80 mmHg) | 20 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough BP Normality Classes | High-normal (SBP<140 DBP<90 mmHg and not normal) | 46 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough BP Normality Classes | Optimal (SBP<120 and DBP<80 mmHg) | 5 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough BP Normality Classes | Normal (SBP<130 and DBP<85 mmHg and not optimal) | 14 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough BP Normality Classes | Stage 1 hypertension (SBP<160 and DBP<100 mmHg | 23 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough BP Normality Classes | Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg) | 3 patients |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Trough BP Normality Classes | Stage 1 hypertension (SBP<160 and DBP<100 mmHg | 43 patients |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Trough BP Normality Classes | Normal (SBP<130 and DBP<85 mmHg and not optimal) | 13 patients |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Trough BP Normality Classes | Optimal (SBP<120 and DBP<80 mmHg) | 3 patients |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Trough BP Normality Classes | High-normal (SBP<140 DBP<90 mmHg and not normal) | 29 patients |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Trough BP Normality Classes | Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg) | 4 patients |
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 and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP\>90 or investigator opinion.
Time frame: up to 34 weeks
Population: 91 is the number of patients titrated to telmisartan 80mg. To get 582 you need to consider the randomised to telmisartan 80 mg patients and those with additional antihypertensive that were on telmisartan 80mg.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 10mg | Trough DBP Control Pre- and Post- Uptitration | Post-titration: No (DBP>=90 mmHg) | 18 patients |
| Telmisartan 40mg and Amlodipine 10mg | Trough DBP Control Pre- and Post- Uptitration | Post-titration: Yes (DBP<90 mmHg) | 306 patients |
| Telmisartan 40mg and Amlodipine 10mg | Trough DBP Control Pre- and Post- Uptitration | Post-titration: Total | 324 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough DBP Control Pre- and Post- Uptitration | Post-titration: Yes (DBP<90 mmHg) | 168 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough DBP Control Pre- and Post- Uptitration | Post-titration: Total | 258 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough DBP Control Pre- and Post- Uptitration | Post-titration: No (DBP>=90 mmHg) | 90 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough DBP Control Pre- and Post- Uptitration | Post-titration: No (DBP>=90 mmHg) | 108 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough DBP Control Pre- and Post- Uptitration | Post-titration: Total | 582 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough DBP Control Pre- and Post- Uptitration | Post-titration: Yes (DBP<90 mmHg) | 474 patients |
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: All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 10mg | Trough Seated DBP Response | Yes (Responder) | 201 patients |
| Telmisartan 40mg and Amlodipine 10mg | Trough Seated DBP Response | No (Non-responder) | 13 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough Seated DBP Response | No (Non-responder) | 29 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough Seated DBP Response | Yes (Responder) | 405 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough Seated DBP Response | Yes (Responder) | 71 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough Seated DBP Response | No (Non-responder) | 16 patients |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Trough Seated DBP Response | Yes (Responder) | 73 patients |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Trough Seated DBP Response | No (Non-responder) | 18 patients |
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: All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan 40mg and Amlodipine 10mg | Trough Seated SBP Response | Yes (Responder) | 190 patients |
| Telmisartan 40mg and Amlodipine 10mg | Trough Seated SBP Response | No (Non-responder) | 24 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough Seated SBP Response | No (Non-responder) | 33 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough Seated SBP Response | Yes (Responder) | 401 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough Seated SBP Response | Yes (Responder) | 75 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough Seated SBP Response | No (Non-responder) | 12 patients |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Trough Seated SBP Response | Yes (Responder) | 69 patients |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Trough Seated SBP Response | No (Non-responder) | 22 patients |
Secondary
Trough Seated Systolic Blood Pressure (SBP) Control
The number of patients who reached 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 10mg | Trough Seated Systolic Blood Pressure (SBP) Control | Yes (SBP<140 mmHg) | 179 patients |
| Telmisartan 40mg and Amlodipine 10mg | Trough Seated Systolic Blood Pressure (SBP) Control | No (SBP>=140 mmHg) | 37 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough Seated Systolic Blood Pressure (SBP) Control | No (SBP>=140 mmHg) | 70 patients |
| Randomised Telmisartan 80mg and Amlodipine 10mg | Trough Seated Systolic Blood Pressure (SBP) Control | Yes (SBP<140 mmHg) | 366 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough Seated Systolic Blood Pressure (SBP) Control | No (SBP>=140 mmHg) | 21 patients |
| Titrated Telmisartan 80mg and Amlodipine 10mg | Trough Seated Systolic Blood Pressure (SBP) Control | Yes (SBP<140 mmHg) | 70 patients |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Trough Seated Systolic Blood Pressure (SBP) Control | Yes (SBP<140 mmHg) | 51 patients |
| Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on | Trough Seated Systolic Blood Pressure (SBP) Control | No (SBP>=140 mmHg) | 41 patients |