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.

Study Type: Interventional

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

Study Primary Completion Date: November 2009

Intervention(s) in this Clinical Trial

• Drug: Aliskiren
  • Aliskiren 150mg, or 300mg, oral, once per day.
• Drug: Ramipril
  • Ramipril 5mg, or 10 mg, oral, once per day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Aliskiren 150mg, or 300mg, oral, once per day.
• Active Comparator: 2
  • Ramipril 5mg, or 10 mg, oral, once per day

Primary Measures

• Occurrence of colonic pathology as defined by the composite endpoint (hyperplastic polyps, inflammatory polyps, adenomatous polyps or carcinomas) after one year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen
  • Time Frame: 1 year
    Safety Issue?: Yes

Secondary Measures

• To assess mucosal hyperplasia, dysplasia, and severity of inflammation in rectal and cecal mucosal biopsy specimens obtained at baseline and following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen
  • Time Frame: 1 year
    Safety Issue?: Yes
• To assess the occurrence of the individual components of the composite endpoint following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.
  • Time Frame: 1 year
    Safety Issue?: Yes
• To assess the number of each component of the composite endpoint following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.
  • Time Frame: 1 year
    Safety Issue?: Yes
• To evaluate the overall gastrointestinal tolerability following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.
  • Time Frame: 1 year
    Safety Issue?: Yes

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 Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Chair 862-778-8300  

Information obtained from ClinicalTrials.gov on August 29, 2008

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