Official Title: “An Eight Week, Double-Blind, Randomized, Multicenter, Parallel Group, Active-Controlled Study Comparing the Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg to Ramipril 5 mg in Patients With Essential Hypertension”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

• Drug: Aliskiren
  • Aliskiren
• Drug: Ramipril
  • comparator

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Aliskiren
• Active Comparator: 2
  • Ramipril

Primary Measures

• To evaluate whether aliskiren 300 mg has non-inferior efficacy compared to ramipril 5 mg on reduction in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint in patients with essential hypertension.

Secondary Measures

• To evaluate whether aliskiren 300 mg and aliskiren 150 mg have superior efficacy compared to ramipril 5 mg on systolic and diastolic BP, if the non-inferiorities in primary objectives are achieved.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Chair Novartis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00529451

Study ID Number: CSPP100A2339

ClinicalTrials.gov Identifier: NCT00529451

Health Authority: China: State Food and Drug Administration