Telmisartan (Micardis) and Ramipril (Altace) - Factorial Design Study for the Treatment of Hypertension



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/30/2017
Start Date:April 2006

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A Randomized, Double-blind, Double-dummy, Placebo-controlled, 3x4 Factorial Design Trial to Evaluate Telmisartan 20 and 80 mg Tablets in Combination With Ramipril 1.25, 10, and 20 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-study

To identify dose combinations of telmisartan and ramipril that are more effective in reducing
diastolic blood pressure than each of the respective monotherapies in patients with Stage I
or II hypertension.


Inclusion Criteria:

- Male and female patients >=18 years of age with Stage I or II hypertension defined as:

- a mean seated cuff diastolic blood pressure >=95 and <=119 mmHg Main

Exclusion Criteria:

- Pregnant

- breast-feeding

- unwilling to use birth control during the study

- secondary hypertension

- SBP>=180 mmHg

- DBP>=120 mmHg

- severe renal dysfunction

- hepatic insufficiency

- stroke within the last 6 months

- myocardial infarction, cardiac surgery, percutaneous transluminal coronary
angioplasty, unstable angina or coronary artery bypass graft within the past three
months

- unstable or uncontrolled diabetes

- history of angioedema of either of the study drugs, and hypersensitivity to the study
drugs.
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