A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension
This study has been completed.
Information provided by:
First received: March 3, 2008
Last updated: June 30, 2011
Last verified: June 2011
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.
Other: Placebo to Ramipril
Other: Placebo to Aliskiren
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Percentage of Participants With Colonic Pathology [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Percentage of Participants With Each of the Individual Components of Colonic Pathology [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: No ]The mean sitting blood pressure control target is defined as less than 140/90 mmHg (or 130/80 mmHg for diabetic patients)
|Study Start Date:||February 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
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 dayOther: 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 dayOther: Placebo to Aliskiren
Placebo tablets to match aliskiren.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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|
Sponsors and Collaborators