Conditions: Hypertension
Keywords: Hypertension valsartan
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2337
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target arm 2: Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study. arm 3: Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.

Interventions: intervention 1: Valsartan and hydrochlorothiazide (HCTZ) - monotherapy intervention 2: Valsartan and amlodipine intervention 3: Usual care intervention 4: Valsartan intervention 5: Valsartan and hydrochlorothiazide (HCTZ) - combination arm
Intervention descriptions: intervention 1: Monotherapy arm - if monotherapy valsartan 320mg per day orally was not sufficient, then could add HCTZ up to 25 mg per day orally intervention 2: From valsartan 80mg/amlodipine 5mg per day to valsartan 160mg/amlodipine 10mg per day orally intervention 3: As directed by investigator intervention 4: Valsartan 160mg per day to 320mg per day orally intervention 5: Combination arm - from valsartan 80mg/hydrochlorothiazide 12.5mg per day to valsartan 160mg/hydrochlorothiazide 25mg per day orally

Protocol document: