Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

Novartis

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: Aliskiren/amlodipine 150/5 mg; Drug: Amlodipine 2.5 mg; Drug: Aliskiren 150 mg; Drug: Placebo of Amlodipine; Drug: Placebo of Aliskiren; Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg; Drug: Placebo of Aliskiren/amlodipine 150/5 mg; Drug: Aliskiren/Amlodipine 150/2.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01237223

CSPA100A1301

Details and patient eligibility

About

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.

Enrollment: 1,342 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with essential hypertension (msDBP ≥ 95 mmHg and < 110 mmHg and msSBP ≥140 mmHg )
• Outpatients

Exclusion criteria

• Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
• History of allergy or hypersensitivity to renin inhibitors, calcium channel blockers
• History or evidence of a secondary hypertension

Other protocol-defined inclusion/exclusion criteria applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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1,342 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg

Drug: Placebo of Aliskiren/amlodipine 150/5 mg

Drug: Placebo of Aliskiren

Drug: Placebo of Amlodipine

Aliskiren 150 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Aliskiren 150 mg

Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg

Drug: Placebo of Aliskiren/amlodipine 150/5 mg

Drug: Placebo of Amlodipine

Amlodipine 2.5 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Amlodipine 2.5 mg

Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg

Drug: Placebo of Aliskiren/amlodipine 150/5 mg

Drug: Placebo of Aliskiren

Drug: Placebo of Amlodipine

Amlodipine 5 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Amlodipine 2.5 mg

Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg

Drug: Placebo of Aliskiren/amlodipine 150/5 mg

Drug: Placebo of Aliskiren

Aliskiren/amlodipine 150/2.5 mg

Experimental group

Description:

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.

Treatment:

Drug: Placebo of Aliskiren/amlodipine 150/5 mg

Drug: Aliskiren/Amlodipine 150/2.5 mg

Drug: Placebo of Aliskiren

Drug: Placebo of Amlodipine

Aliskiren/amlodipine 150/5 mg

Experimental group

Description:

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.

Treatment:

Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg

Drug: Placebo of Aliskiren

Drug: Placebo of Amlodipine

Drug: Aliskiren/amlodipine 150/5 mg