- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00631917
A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension
June 30, 2011 updated by: Novartis
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
774
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Investigative Site, Argentina
- Investigative Site
-
-
-
-
-
Investigative Site, Colombia
- Investigative Site
-
-
-
-
-
Investigative Site, France
- Investigative Site
-
-
-
-
-
Investigative Site, Germany
- Investigative Site
-
-
-
-
-
investigative Site, India
- Investigative Site
-
-
-
-
-
Investigative Site, Spain
- Investigative Site
-
-
-
-
Missouri
-
Kansas City, Missouri, United States
- Investigative Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aliskiren
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
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
Placebo tablets to match aliskiren.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
54 weeks
|
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.
|
54 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
54 weeks
|
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.
|
54 weeks
|
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)
|
Weeks 8, 30 and End of Study (54 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Novartis, 862-778-8300
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
March 3, 2008
First Submitted That Met QC Criteria
March 7, 2008
First Posted (Estimate)
March 10, 2008
Study Record Updates
Last Update Posted (Estimate)
July 12, 2011
Last Update Submitted That Met QC Criteria
June 30, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSPP100A2404
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Addpharma Inc.Completed
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
Clinical Trials on Aliskiren
-
NovartisCompletedHypertensionSlovakia, Italy, Netherlands, Argentina, Germany, Poland, Czech Republic, Iceland
-
NovartisCompletedEssential HypertensionGermany, Spain, United States
-
Novartis PharmaceuticalsCompletedHypertensionUnited States, Belgium, Hungary, Turkey, Guatemala, Slovakia, Germany, Puerto Rico, Poland
-
Novartis PharmaceuticalsCompleted
-
NovartisCompleted
-
University of Campania "Luigi Vanvitelli"IRCCS San RaffaeleUnknownHypertension | End Stage Renal Disease
-
NovartisCompletedHypertensionUnited States
-
NovartisCompleted
-
NovartisCompleted
-
NovartisCompleted