Conditions: Hypertension
Keywords: Aliskiren, Amlodipine, Non-responder to aliskiren
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 818
Healthy volunteers: no

Brief summary:
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone

Detailed description:

Arms:
arm 1: Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks. arm 2: Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks. arm 3: Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.

Interventions: intervention 1: Aliskiren 300 mg intervention 2: Aliskiren/Amlodipine 300/5 mg intervention 3: Aliskiren/Amlodipine 300/10 mg intervention 4: Placebo to Aliskiren intervention 5: Placebo to Aliskiren/Amlodipine
Intervention descriptions: intervention 1: Aliskiren 300 mg tablet taken orally once a day with a glass of water. intervention 2: Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water. intervention 3: Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water. intervention 4: Placebo to Aliskiren tablet taken orally once a day. intervention 5: Placebo to Aliskiren/Amlodipine taken orally once a day.

Protocol document: