At a glance
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A Phase IV Clinical Trial of Intensified Blood Pressure Management in Primary Care Using Valsartan Alone and as Combination Anti-Hypertensive Therapy
In Brief
A Phase 4 clinical trial evaluating Valsartan and hydrochlorothiazide (HCTZ) - monotherapy, Valsartan and amlodipine, and 3 other interventions for Hypertension. Completed, enrolled 2,337 participants across 3 sites in 2 countries.
Detailed Summary
This study will assess the efficacy of an intensive blood pressure management strategy compared to usual care in a primary care (general practice) setting.
Study Details
Timeline
Interventions
Monotherapy arm - if monotherapy valsartan 320mg per day orally was not sufficient, then could add HCTZ up to 25 mg per day orally
From valsartan 80mg/amlodipine 5mg per day to valsartan 160mg/amlodipine 10mg per day orally
As directed by investigator
Valsartan 160mg per day to 320mg per day orally
Combination arm - from valsartan 80mg/hydrochlorothiazide 12.5mg per day to valsartan 160mg/hydrochlorothiazide 25mg per day orally