At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Amlodipine, Olmesartan medoxomil, and 2 other interventions for Hypertension. Completed, enrolled 257 participants across 2 sites.
Detailed 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).
Study Details
Timeline
Interventions
Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only.
Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only.
Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase.
Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase.