drugset / Trial / NCT00750113

Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control.

NCT00750113

Phase 4 Completed 405 enrolled Bayer
RandomizedParallel-groupDouble-blindTreatment

Summary

Patients having uncontrolled or poorly controlled hypertension are at risk of experiencing cardiovascular events such as myocardial infarction or stroke. To reduce this risk an appropriate antihypertensive therapy should allow to reach a target blood pressure of less than 130/80 mmHg in order to maximise cardiovascular protection.The purpose of this study is to evaluate the efficacy in blood pressure control when anti-hypertensive therapy is initiated with a combination of low dose Nifedipine GITS and Telmisartan compared to a regimen starting with monotherapy before adding the other drug.The primary efficacy parameter will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring (ABPM) at 16 weeks of treatment compared to baseline

Timeline

Start
2007-10
Primary completion
2009-07
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Nifedipine Other / unclassified 20 mg
Subject Telmisartan Other / unclassified 80 mg

Indications