Prospective Randomised Investigation of the Safety and Efficacy of Micardis® vs Ramipril Using ABPM (PRISMA)
The primary objective of this study is to demonstrate that telmisartan 80 mg (MICARDIS®) is at least as effective and possibly superior to ramipril 5mg and 10mg in lowering mean ambulatory diastolic blood pressure (DBP) and systolic blood pressure (SBP) during the last 6 hours of the 24-hour dosing interval in mild-to-moderate hypertensive patients at the end of an 8 and 14-week treatment period, respectively.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Prospective Randomised Open- Label Blinded-Endpoint (PROBE) Trial Comparing Telmisartan (MICARDIS®) (40-80-80mg QD) and Ramipril (2.5-5-10mg QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring|
- Changes from baseline in the last 6 hour mean (relative to dose time) diastolic blood pressure and systolic blood pressure as measured by ABPM at the end of both an 8-week treatment period and a 14-week treatment period.
|Study Start Date:||October 2002|
|Estimated Study Completion Date:||November 2003|
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|Study Chair:||Boehringer Ingelheim Study Coordinator||Boehringer Ingelheim Ltd./Bracknell|