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
- Male or female outpatients, 50 years of age and older with a diagnosis of essential
- 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).
- 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,
- 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.