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

Boehringer Ingelheim838 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

838

Conditions

Hypertension

Interventions

fixed-dose combination of telmisartan 40mg+amlodipine 10mgDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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)

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

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)

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

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)

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)

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)

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)

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

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

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

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (92)

Outcomes

Primary Outcomes

Secondary Outcomes