Conditions: Hypertension
Keywords: Systolic blood pressure Diastolic blood pressure Valsartan Hydrochlorothiazide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 384
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 hypertension

Detailed description:

Arms:
arm 1: (patients initiated on valsartan) arm 2: (patients initiated on HCTZ) arm 3: (patients initiated on Valsartan+HCTZ)

Interventions: intervention 1: Valsartan + HCTZ intervention 2: Valsartan intervention 3: HCTZ
Intervention descriptions: intervention 1: At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12. intervention 2: At week 0 patients received Valsartan(V) 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12. intervention 3: At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.

Protocol document: