Status:
COMPLETED
A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
774 Patients enrolled
Trial Details
Trial ID
NCT00631917
Start Date
February 1 2008
End Date
September 1 2009
Last Update
July 12 2011
Active Locations (7)
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1
Investigative Site
Kansas City, Missouri, United States
2
Investigative Site
Investigative Site, Argentina
3
Investigative Site
Investigative Site, Colombia, Colombia
4
Investigative Site
Investigative Site, France