Clinical trial NCT01237223
Conditions: Essential Hypertension
Keywords: Aliskiren Amlodipine Essential hypertension
Sponsor: Novartis
Start date: 2010-10-01; Completion date: 2011-05-01
Enrollment: 1342 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with essential hypertension (mean sitting diastolic blood pressure \[msDBP\] ≥ 95 mmHg and \< 110 mmHg and mean sitting systolic blood pressure \[msSBP\] ≥ 140 mmHg ). This study was conducted to support registration of the fixed-dose combination of aliskiren and amlodipine for the treatment of hypertension in Japan.

Detailed description:

Arms: arm 1: In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily. arm 2: In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.

Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. arm 3: In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.

Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period. arm 4: In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.

Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period. arm 5: In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.

Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period. arm 6: In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.

Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
Interventions: intervention 1: Aliskiren/Amlodipine 150/2.5 mg intervention 2: Aliskiren/amlodipine 150/5 mg intervention 3: Aliskiren 150 mg intervention 4: Amlodipine 2.5 mg intervention 5: Placebo of Aliskiren intervention 6: Placebo of Amlodipine intervention 7: Placebo of Aliskiren/amlodipine 150/2.5 mg intervention 8: Placebo of Aliskiren/amlodipine 150/5 mg
Intervention descriptions: intervention 1: Aliskiren/amlodipine 150/2.5 mg tablet intervention 2: Aliskiren/amlodipine 150/5 mg tablet intervention 3: Aliskiren 150 mg tablet intervention 4: Amlodipine 2.5 mg capsule intervention 5: Aliskiren placebo tablet intervention 6: Amlodipine placebo capsule intervention 7: Aliskiren/amlodipine 150/2.5 mg placebo tablet intervention 8: Aliskiren/amlodipine 150/5 mg placebo tablet

Protocol documents: