NCT00360178

Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Fixed Dose Combination in Hypertensive Patients Not Controlled by the Free Combination of an Angiotensin Receptor Blocker Plus Hydrochlorothiazide

An Open-label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Valsartan 160 mg Plus HCTZ 25 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker (Candesartan 32 mg) Plus HCTZ 25 mg

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Recruiting in Germany only: This study will evaluate the safety and efficacy of valsartan plus HCTZ in fixed dose combination in hypertensive patients not responding to treatment with the free combination of Candesartan plus HCTZ. In an optional extension patients with uncontrolled BP at the end of the core study can be treated with valsartan plus HCTZ in fixed dose combination plus amlodipine 5 mg for additional 4 weeks.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Valsartan plus Hydrochlorothiazide
DRUG	Candesartan plus Hydrochlorothiazide
DRUG	Amlodipine

Timeline

• Start date: 2006-07-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2006-08-04
• Last updated: 2016-11-18

Locations

2 sites across 2 countries: Germany, Switzerland