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Clinical Trial Summary

The purpose of this study is to compare the blood pressure lowering efficacy of a treatment regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin II type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide diuretic combined with a beta-blocker.


Clinical Trial Description

Primary objective:

Sitting systolic blood pressure (average of three readings) will be the primary outcome variable.

Secondary

1. To compare the time interval between the two treatment groups, which after randomisation will be required, to reach and maintain the target defined as a blood pressure below 140 mm Hg systolic and 90 mm Hg diastolic;

2. To compare the duration of follow-up, during which a steady blood pressure control will be achieved;

3. To evaluate the incidence of adverse events, symptoms, biochemical abnormalities and ECG changes in the two treatment groups;

4. To assess the adherence to antihypertensive treatment as well as the rate of drop-outs in both treatment arms during a six-month period. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01030458
Study type Interventional
Source Katholieke Universiteit Leuven
Contact
Status Completed
Phase Phase 4
Start date September 2010
Completion date March 2012

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