A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension
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|ClinicalTrials.gov Identifier: NCT00631917|
Recruitment Status : Completed
First Posted : March 10, 2008
Results First Posted : June 21, 2011
Last Update Posted : July 12, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Aliskiren Drug: Ramipril Other: Placebo to Ramipril Other: Placebo to Aliskiren||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||774 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
For the first 2 weeks of the study, participants received aliskiren 150 mg once a day and were then forced titrated to aliskiren 300 mg once a day for 52 weeks. Participants also received a placebo capsule to match ramipril once a day for the study duration.
Aliskiren 300 mg once a day
Other: Placebo to Ramipril
Placebo capsules to match ramipril.
Active Comparator: Ramipril
For the first 2 weeks of the study participants received 5 mg ramipril orally once a day and were then forced titrated to ramipril 10 mg once a day for 52 weeks. Participants also received placebo to aliskiren for the duration of the study.
Ramipril 10 mg once a day
Other: Placebo to Aliskiren
Placebo tablets to match aliskiren.
- Percentage of Participants With Colonic Pathology [ Time Frame: 54 weeks ]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.
- Summary of the End of Study Colonoscopy Results [ Time Frame: 54 weeks ]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.
- Percentage of Participants With Each of the Individual Components of Colonic Pathology [ Time Frame: 54 weeks ]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.
- Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment [ Time Frame: 54 weeks ]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.
- Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target [ Time Frame: Weeks 8, 30 and End of Study (54 weeks) ]The mean sitting blood pressure control target is defined as less than 140/90 mmHg (or 130/80 mmHg for diabetic patients)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631917
|United States, Missouri|
|Kansas City, Missouri, United States|
|Investigative Site, Argentina|
|Investigative Site, Colombia|
|Investigative Site, France|
|Investigative Site, Germany|
|investigative Site, India|
|Investigative Site, Spain|