Conditions: Essential Hypertension
Keywords: Essential hypertension High blood pressure
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 564
Healthy volunteers: no

Brief summary:
This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension.

Detailed description:

Arms:
arm 1: Participants received aliskiren 300 milligrams (mg) plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning.

Interventions: intervention 1: Aliskiren intervention 2: Amlodipine intervention 3: Hydrochlorothiazide
Intervention descriptions: intervention 1: 300 mg tablet intervention 2: 5 mg tablet intervention 3: 12.5 mg and 25 mg capsule

Protocol document: