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

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Aliskiren 300 mg
  • Aliskiren 300 mg once daily
• Experimental: Aliskiren 150 mg
  • Aliskiren 150 mg once daily
• Experimental: Aliskiren 75 mg
  • Aliskiren 75 mg once daily
• Active Comparator: Ramipril 5 mg
  • Ramipril 5 mg once daily

Primary Measures

• Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)
  • Time Frame: Baseline and Week 8
    Safety Issue?: No

Secondary Measures

• Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint
  • Time Frame: Baseline and Week 8
    Safety Issue?: No
• Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg
  • Time Frame: Week 8
    Safety Issue?: No
• Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP
  • Time Frame: Week 8
    Safety Issue?: No

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 Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Study Chair Novartis  

Information obtained from ClinicalTrials.gov on February 12, 2012

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