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

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Aliskiren 150; Drug: Amlodipine 10 mg; Drug: Amlodipine 300

Study type: Interventional

Funder types: Industry

Identifiers

NCT00778921

CSPA100A2304

Details and patient eligibility

About

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

Enrollment: 847 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 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 5 (randomization)

Exclusion criteria

• Severe hypertension
• Pregnant or nursing (lactating) women
• Pre-menopausal women not taking accepted form of birth control
• Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
• History of cardiovascular conditions
• Uncontrolled Type 1 or Type 2 diabetes mellitus
• Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures

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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847 participants in 3 patient groups

Amlodipine 10 mg

Experimental group

Description:

Amlodipine 10 mg

Treatment:

Drug: Amlodipine 10 mg

Aliskiren/Amlodipine 150/10 mg

Experimental group

Description:

Aliskiren/Amlodipine 150/10 mg

Treatment:

Drug: Aliskiren 150

Drug: Amlodipine 10 mg

Aliskiren/Amlodipine 300/10 mg

Experimental group

Description:

Aliskiren/Amlodipine 300/10 mg

Treatment:

Drug: Amlodipine 300

Drug: Amlodipine 10 mg