An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Aliskiren; Drug: Hydrochlorothiazide; Drug: Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00402103

CSPA100A2301

Details and patient eligibility

About

To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure [msDBP] ≥ 90 mmHg and < 110 mmHg).

Enrollment: 556 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients 18 years of age or older
• Male or female patients are eligible
• For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg at Visit 1 and Visit 4
• For previously treated patients with essential hypertension defined as msDBP ≥ 90 and < 110 mmHg after 2 to 4 weeks of washout (Visit 4)

Exclusion criteria

• Severe hypertension
• History or evidence of a secondary form of hypertension
• History of Hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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556 participants in 2 patient groups

Aliskiren/Amlodipine

Experimental group

Treatment:

Drug: Amlodipine

Drug: Aliskiren

Aliskiren/Amlodipine/HCTZ

Experimental group

Treatment:

Drug: Hydrochlorothiazide

Drug: Amlodipine

Drug: Aliskiren