2,337
Participants
Start Date
July 31, 2009
Primary Completion Date
July 31, 2011
Study Completion Date
July 31, 2011
Valsartan and hydrochlorothiazide (HCTZ) - monotherapy
Monotherapy arm - if monotherapy valsartan 320mg per day orally was not sufficient, then could add HCTZ up to 25 mg per day orally
Valsartan and amlodipine
From valsartan 80mg/amlodipine 5mg per day to valsartan 160mg/amlodipine 10mg per day orally
Usual care
As directed by investigator
Valsartan
Valsartan 160mg per day to 320mg per day orally
Valsartan and hydrochlorothiazide (HCTZ) - combination arm
Combination arm - from valsartan 80mg/hydrochlorothiazide 12.5mg per day to valsartan 160mg/hydrochlorothiazide 25mg per day orally
Novartis Pharmaceuticals, East Hanover
Professor Garry Jennings-Co Principal Investigator, Melbourne
Professor Simon Stewart-Principal Investigator, Melbourne
Lead Sponsor
Baker Heart and Diabetes Institute
OTHER
Novartis Pharmaceuticals
INDUSTRY