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A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00631917
First received: March 3, 2008
Last updated: June 30, 2011
Last verified: June 2011

March 3, 2008
June 30, 2011
February 2008
September 2009   (final data collection date for primary outcome measure)
  • 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.
Occurrence of colonic pathology as defined by the composite endpoint (hyperplastic polyps, inflammatory polyps, adenomatous polyps or carcinomas) after one year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00631917 on ClinicalTrials.gov Archive Site
  • 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)
  • To assess mucosal hyperplasia, dysplasia, and severity of inflammation in rectal and cecal mucosal biopsy specimens obtained at baseline and following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • To assess the occurrence of the individual components of the composite endpoint following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • To assess the number of each component of the composite endpoint following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • To evaluate the overall gastrointestinal tolerability following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • Drug: Aliskiren
    Aliskiren 300 mg once a day
  • Drug: Ramipril
    Ramipril 10 mg once a day
  • Other: Placebo to Ramipril
    Placebo capsules to match ramipril.
  • Other: Placebo to Aliskiren
    Placebo tablets to match aliskiren.
  • 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.
    Interventions:
    • Drug: Aliskiren
    • Other: Placebo to 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.
    Interventions:
    • Drug: Ramipril
    • Other: Placebo to Aliskiren
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
774
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Colombia,   France,   Germany,   India,   Spain
 
NCT00631917
CSPP100A2404
No
Study Director, Novartis Pharmaceuticals
Novartis
Not Provided
Study Chair: Novartis 862-778-8300
Novartis
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP