An Eight-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 40mg + Amlodipine 10mg Versus Telmisartan 80mg + Amlodipine 10mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 10mg Monotherapy

Boehringer Ingelheim97 sites in 9 countries947 target enrollmentNovember 2007

ConditionsHypertension

Drugsfixed dose combination of telmisartan+amlodipine amlodipine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Enrollment: 947
Locations: 97
Primary Endpoint: Change From Baseline in Trough Seated Diastolic Blood Pressure
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan 80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks treatment with A10.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

October 2008

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility Criteria

Inclusion Criteria

•diagnosis of essential hypertension and blood pressure not adequately controlled before informed consent (inadequate control defined as seated diastolic blood pressure (DBP) \>= 95 mmHg if on existing antihypertensive treatment or seated DBP \>= 100 mmHg if treatment-naïve).
•failure to respond to six weeks treatment with amlodipine 10mg. (Failure to respond defined as seated DBP \>= 90 mmHg.)
•able to stop any current antihypertensive therapy without unacceptable risk to the patient.
•willing and able to provide written informed consent.

Exclusion Criteria

•pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
•known or suspected secondary hypertension.
•mean seated systolic blood pressure (SBP) \>=200 mmHg and/or mean seated DBP \>= 120 mmHg during run-in treatment or mean seated SBP \>= 180 mmHg and/or mean seated DBP \>= 120 mmHg at the randomisation visit or at any time during randomised treatment.
•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 ACE inhibitors or ARBs.

Outcomes

Primary Outcomes

Change From Baseline in Trough Seated Diastolic Blood Pressure

Time Frame: Baseline and end of study (8 weeks or last value on treatment)

Change from baseline to the end of study in trough DBP

Secondary Outcomes

Change From Baseline in Trough Seated Systolic Blood Pressure(Baseline and end of study (8 weeks or last value on treatment))
Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)(End of study (8 weeks or last value on treatment))
Trough Seated Diastolic Blood Pressure <80 mmHg(End of study (8 weeks or last value on treatment))
Trough Seated DBP Response(End of study (8 weeks or last value on treatment))
Trough Seated SBP Control(End of study (8 weeks or last value on treatment))
Trough Seated BP Normality Classes(End of study (8 weeks or last value on treatment))
Oedema Incidence Rate(During randomised treatment period)
Peripheral Oedema Incidence Rate(During randomised treatment period)
Trough Seated SBP Response(End of study (8 weeks or last value on treatment))