Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Aliskiren/Amlodipine 300/10 mg; Drug: Aliskiren/Amlodipine 300/5 mg; Drug: Aliskiren 300 mg; Drug: Placebo to Aliskiren; Drug: Placebo to Aliskiren/Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00777946

CSPA100A2303

Details and patient eligibility

About

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

Enrollment: 818 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a mean sitting Diastolic Blood Pressure (msDBP) ≥ 95 mmHg and < 110 mmHg at Visits 1 and 2
• Patients who have been treated for hypertension within the 4 weeks prior to - Visit 1 must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 2
• All patients must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 4

Exclusion criteria

• Severe hypertension
• Pregnant or nursing (lactating) women
• Women of child-bearing potential
• Previous or current diagnosis of heart failure New York Heart Association (NYHA Class II-IV)
• Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
• Uncontrolled Type 1 or Type 2 diabetes mellitus
• Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
• History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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818 participants in 3 patient groups

Aliskiren 300 mg/Amlodipine 5 mg

Experimental group

Description:

Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.

Treatment:

Drug: Aliskiren/Amlodipine 300/5 mg

Drug: Placebo to Aliskiren

Aliskiren 300 mg/Amlodipine 10 mg

Experimental group

Description:

Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks.

Treatment:

Drug: Aliskiren/Amlodipine 300/10 mg

Drug: Placebo to Aliskiren

Aliskiren 300 mg

Active Comparator group

Description:

Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.

Treatment:

Drug: Aliskiren 300 mg

Drug: Placebo to Aliskiren/Amlodipine