Conditions: Hypertension
Keywords: Hypertension, aliskiren, amlodipine, HCTZ, blood pressure
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 556
Healthy volunteers: no

Brief summary:
To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 mmHg and \< 110 mmHg).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Aliskiren intervention 2: Amlodipine intervention 3: Hydrochlorothiazide
Intervention descriptions: intervention 1: All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration intervention 2: All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration intervention 3: Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.

Protocol document: