NCT00523744

Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

An Open-label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Amlodipine 10 mg Plus Valsartan 160 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker (Olmesartan 20 mg) Plus Amlodipine 10 mg

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).

Detailed description

Title of study extension: An open-label, multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 12.5 mg plus amlodipine 10 mg/valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus amlodipine 10 mg followed by amlodipine 10 mg/valsartan 160 mg

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Amlodipine	Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only.
DRUG	Olmesartan medoxomil	Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only.
DRUG	Amlodipine+valsartan	Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase.
DRUG	Hydrochlorothiazide	Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase.

Timeline

• Start date: 2007-07-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-08-31
• Last updated: 2020-08-04
• Results posted: 2011-05-25

Locations

2 sites across 1 country: Germany