Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Ramipril

Criteria

Inclusion Criteria:

• Outpatients > 18 years

• Male or female patients. Female patients must have been either post-menopausal for one year, surgically sterile, or using effective contraceptive methods

• Patients with essential hypertension, previously treated with an antihypertensive single-drug therapy, either uncontrolled or intolerant.

• BP thresholds at visit 1:

• For patients previously treated and uncontrolled: 140≤ office SBP<180 mmHg

• For patients previously treated, controlled but intolerant: office SBP≥130 mmHg

• BP thresholds at visit 2 (for all patients):

• 160≤office SBP<180 mmHg AND

• 155≤home SBP<175 mmHg (3-day period of home blood pressure monitoring just before randomization)

Exclusion Criteria:

• Women of child-bearing potential not using any effective methods of contraception

• Severe hypertension (office BP ≥ 180/110 mmHg)

• Impossibility to stop abruptly previous antihypertensive treatments at visit 1

• Patients previously untreated or patients treated with two or three antihypertensive medications

• History or evidence of a secondary form of hypertension

• History of hypersensitivity to ACEi or renin inhibitors

• History of heart failure, stroke or coronary heart disease

• Serum potassium ≥ 5.2 mmol/l

Other protocol-defined inclusion/exclusion criteria may apply