Skip to main content
OpenTrials
Completed

NCT Number: NCT00631917

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigative Site, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aliskiren

Drug

Aliskiren 300 mg once a day

Ramipril

Drug

Ramipril 10 mg once a day

Placebo to Ramipril

Other

Placebo capsules to match ramipril.

Placebo to Aliskiren

Other

Placebo tablets to match aliskiren.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 10, 2008
Registry last updated
Jul 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.