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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
774
Aliskiren 300 mg once a day
Ramipril 10 mg once a day
Placebo capsules to match ramipril.
Investigative Site
Kansas City, Missouri, United States
Investigative Site
Investigative Site, Argentina
Investigative Site
Investigative Site, Colombia, Colombia
Investigative Site
Investigative Site, France
Percentage of Participants With Colonic Pathology
The primary analysis variable was the occurrence of an abnormal colonoscopy finding (defined as hyper-plastic polyps, inflammatory polyps, adenomatous polyps or carcinoma) at or prior to the planned one year visit. The occurrence of colonic pathology was identified during colonoscopy and histopathologic examination of biopsy. The composite endpoint was evaluated after one year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.
Time frame: 54 weeks
Summary of the End of Study Colonoscopy Results
During each colonoscopy procedure, random biopsy samples were taken from normal appearing mucosa in both the cecum and rectum in addition to obvious endoscopically atypical areas. The mucosal biopsy samples were evaluated for mucosal hyperplasia, dysplasia, and inflammation. Anything noted as a distinct visual abnormality from cecum to rectum such as ulcers, erythematous mucosa, or polyps, was photographed and biopsied for histopathology evaluation. Colonic lesions were categorized according to location in the colon, size, number, and morphology.
Time frame: 54 weeks
Percentage of Participants With Each of the Individual Components of Colonic Pathology
Assessment of the occurrence of the individual components (hyperplastic polyps, inflammatory polyps, adenomatous polyps or carcinomas) of the composite endpoint (colonic pathology) following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.
Time frame: 54 weeks
Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment
Maximum hyperplasia score at end of study across rectal and cecal mucosa biopsy specimens. Score of 0 is no change from baseline, the minimum possible score. Score \> 0 is worsening from baseline in which the maximum possible score is 3.
Time frame: 54 weeks
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Placebo tablets to match aliskiren.
Investigative Site
Investigative Site, Germany
Investigative Site
Investigative Site, India
Investigative Site
Investigative Site, Spain
Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target
The mean sitting blood pressure control target is defined as less than 140/90 mmHg (or 130/80 mmHg for diabetic patients)
Time frame: Weeks 8, 30 and End of Study (54 weeks)