Conditions: Hypertension
Keywords: Hypertension Metabolic Syndrome aliskiren hydrochlorothiazide systolic blood pressure diastolic blood pressure stage 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 532
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) compared to aliskiren monotherapy when given to metabolic syndrome patients with stage 2 systolic hypertension (mean sitting systolic blood pressure \[msSBP\] ≥ 160 mm Hg and \< 200 mm Hg).

Detailed description:

Arms:
arm 1: Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form. arm 2: Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.

Interventions: intervention 1: Aliskiren intervention 2: Hydrochlorothiazide
Intervention descriptions: intervention 1: Aliskiren 150 mg or 300 mg taken once daily in oral form intervention 2: Hydrochlorothiazide 12.5 mg or 25 mg taken once daily in oral form.

Protocol document: