A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension

Official Title: “A 54 Week, Randomized, Double-blind, Parallel-group, Multicenter Study Evaluating the Long-term Gastrointestinal (GI) Safety and Tolerability of Aliskiren (300 mg) Compared to Ramipril (10 mg) in Patients With Essential Hypertension”

This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.

Intervention(s) in this Clinical Trial

• Drug: Aliskiren
  • Aliskiren 300 mg once a day
• Drug: Ramipril
  • Ramipril 10 mg once a day
• Other: Placebo to Ramipril
  • Placebo capsules to match ramipril.
• Other: Placebo to Aliskiren
  • Placebo tablets to match aliskiren.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Aliskiren
  • For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
• Active Comparator: Ramipril
  • For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.

Primary Measures

• Percentage of Participants With Colonic Pathology
  • Time Frame: 54 weeks
    Safety Issue?: Yes
• Summary of the End of Study Colonoscopy Results
  • Time Frame: 54 weeks
    Safety Issue?: Yes

Secondary Measures

• Percentage of Participants With Each of the Individual Components of Colonic Pathology
  • Time Frame: 54 weeks
    Safety Issue?: Yes
• Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment
  • Time Frame: 54 weeks
    Safety Issue?: Yes
• Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target
  • Time Frame: Weeks 8, 30 and End of Study (54 weeks)
    Safety Issue?: No

Inclusion Criteria:

• Male or female outpatients, 50 years of age and older with a diagnosis of essential hypertension
• Successful high quality colonoscopy at baseline including visualization of the entire colon and the cecum as confirmed by a photograph and collection of the rectal and cecal mucosal biopsy samples
• All rectal, colon or cecal polyps found at baseline colonoscopy must be completely resected endoscopically at the time of the procedure.
• Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation have been clearly explained to them (written informed consent).

Exclusion Criteria:

• Previously treated in an aliskiren study.
• Current evidence of inflammatory bowel disease, the presence of colonic ulcerations (or other indices of colitis of any type) or colorectal carcinoma including carcinoma in situ found at baseline colonoscopy.
• History of gastrointestinal carcinoma, Crohn's disease, ulcerative colitis, microscopic colitis.
• History of familial polyposis or hereditary nonpolyposis colorectal cancer.
• History of confirmed diverticulitis within 12 months of Visit 1.
• History of celiac disease (gluten intolerance).
• History of or current evidence on the baseline colonoscopy of melanosis coli.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 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 862-778-8300  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00631917

Study ID Number: CSPP100A2404

ClinicalTrials.gov Identifier: NCT00631917

Health Authority: United States: Food and Drug Administration