26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension

Study Overview
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Brief Summary
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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).

Official Title
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An Open Label Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 40mg + Amlodipine 10mg or Fixed Dose Combination of Telmisartan 80mg + Amlodipine 10mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: fixed-dose combination of telmisartan 40mg+amlodipine 10mg
* Drug: fixed-dose combination of telmisartan 80mg+amlodipine10mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fixed-dose combination of telmisartan 40mg+amlodipine 10mg|nan|
|Drug: fixed-dose combination of telmisartan 80mg+amlodipine10mg|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough Seated Diastolic Blood Pressure (DBP) Control | The number of patients who reached the target DBP of <90mmHg | End of study (34 weeks or last value on treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough Seated Systolic Blood Pressure (SBP) Control | The number of patients who reached the target SBP of >=140mmHg | End of study (34 weeks or last value on treatment) | 
| 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 | Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment | 
| 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 | Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment) | 
| 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 | Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment | 
| 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 | Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment) | 
| Trough Seated DBP Response | The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg | End of study (34 weeks or last value on treatment) | 
| Trough Seated SBP Response | The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg | End of study (34 weeks or last value on treatment) | 
| Trough BP Normality Classes | The number of patients who reach predefined BP categories | End of study (34 weeks or last value on treatment) | 
| Time to First Additional Antihypertensive | Time from first intake of medication to first intake of an antihypertensive other than the study drug | up to 34 weeks | 
| 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 | up to 34 weeks | 
| 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 | up to 34 weeks | 
| 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 | up to 34 weeks | 
| 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. | up to 34 weeks |