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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
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Aliskiren Drug: Ramipril Other: Placebo to Ramipril Other: Placebo to Aliskiren Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 774 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2008
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.
Drug: Aliskiren
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.
Drug: Ramipril
Ramipril 10 mg once a day
Other: Placebo to Aliskiren
Placebo tablets to match aliskiren.

Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  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)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

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
Investigative Site
Kansas City, Missouri, United States
Investigative Site
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
Sponsors and Collaborators
Study Chair: Novartis 862-778-8300
More Information

Responsible Party: Study Director, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00631917     History of Changes
Other Study ID Numbers: CSPP100A2404
First Posted: March 10, 2008    Key Record Dates
Results First Posted: June 21, 2011
Last Update Posted: July 12, 2011
Last Verified: June 2011

Keywords provided by Novartis:
Hypertension, aliskiren, ramipril, colonoscopy

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents