A Prospective, Randomised, Double-Blind, Double-Dummy, Titration-to-Response Trial Comparing MICARDIS® (Telmisartan) (40 or 80 mg p.o. Once Daily) and COZAAR® / LORZAAR® (Losartan) (50 or 100 mg p.o. Once Daily) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (TOPAS STUDY = Telmisartan and LOsartan ComParative ABPM Study)

NCT02200653 Phase 4 COMPLETED

The primary aim of the trial is to compare the influence of MICARDIS® (telmisartan) and COZAAR® / LORZAAR® (losartan) in lowering ambulatory diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval as measured by ABPM. Secondary objectives include evaluations of: 1) change from baseline in mean systolic blood pressure (SBP) during the last 6 hours of the 24-hour dosing interval as measured by ABPM, 2) changes from baseline in SBP and DBP during other periods during the 24-hour ABPM profile, 3) changes from baseline in mean seated trough SBP and DBP as measured by manual cuff sphygmomanometer, and 4) responder rates based on both ABPM and trough cuff blood pressure

Details

Lead sponsor	Boehringer Ingelheim
Phase	Phase 4
Status	COMPLETED
Enrolment	387
Start date	2000-05

Conditions

• Hypertension

Interventions

• High dose of MICARDIS®, once daily
• Low dose of MICARDIS®, once daily
• Low dose of COZAAR® / LORZAAR®, once daily
• High dose of COZAAR® / LORZAAR®, once daily
• Placebo

Primary outcomes

• Change from baseline in mean diastolic blood pressure — Up to 8 weeks after start of treatment
  Measured during the last 6 hours of the 24-hour dosing interval using ABPM