Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300 mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Ramipril

Criteria

Inclusion Criteria:

• Patients must have msDBP ≥ 90 mmHg and < 110 mmHg at the visit immediately prior to Visit 3

• Patients must have msDBP >OR= 95 mmHg and < 110 mmHg at Visit 3

• Patients must have an absolute difference of < or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3

Exclusion Criteria:

• Severe hypertension (grade 3 WHO classification; msDBP >or= 110 mmHg and/or msSBP >or = 180 mmHg).

• History or evidence of a secondary form of hypertension.

• History of transient ischemic cerebral attack within 12 months of visit 1.

• Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates)

• Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8% at Visit 1.

• Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply.