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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00631917
• Date of registration: 03/03/2008
• Prospective Registration: No
• Primary sponsor: Novartis
• Public title: A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension
• Scientific 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
• Date of first enrolment: February 2008
• Target sample size: 774
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00631917
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Argentina, Colombia, France, Germany, India, Peru, Spain, United States

Contacts

• Name: Novartis
• Affiliation: 862-778-8300

Key inclusion & exclusion criteria

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.



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Other: Placebo to Aliskiren

Other: Placebo to Ramipril

Drug: Ramipril

Drug: Aliskiren

Primary Outcome(s)

Percentage of Participants With Colonic Pathology [Time Frame: 54 weeks]

Summary of the End of Study Colonoscopy Results [Time Frame: 54 weeks]

Secondary Outcome(s)

Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target [Time Frame: Weeks 8, 30 and End of Study (54 weeks)]

Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment [Time Frame: 54 weeks]

Percentage of Participants With Each of the Individual Components of Colonic Pathology [Time Frame: 54 weeks]

Secondary ID(s)

CSPP100A2404

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/06/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00631917