Phase 4
Completed N=774
A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension
Source: ClinicalTrials.gov NCT00631917 ↗Enrolled (actual)
774
Serious AEs
6.5%
Results posted
Jun 2011
Primary outcomePrimary: Percentage of Participants With Colonic Pathology — 25.5; 25.1 Percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Colonic Pathology |
25.5; 25.1 | — |
| PRIMARY Summary of the End of Study Colonoscopy Results |
100; 100; 99.7; 100; 99.4; 99.7 | — |
| SECONDARY Percentage of Participants With Each of the Individual Components of Colonic Pathology |
13.1; 10.2; 0.0; 0.3; 15.0; 17.3 | — |
| SECONDARY Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment |
295; 304; 17; 19; 0; 0 | — |
| SECONDARY Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target |
50.8; 44.9; 60.2; 54.1; 65.0; 56.1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00631917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.