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

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Aliskiren; Drug: Ramipril; Other: Placebo to Ramipril; Other: Placebo to Aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT00631917

CSPP100A2404

Details and patient eligibility

About

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.

Enrollment: 774 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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774 participants in 2 patient groups

Aliskiren

Experimental group

Description:

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.

Treatment:

Other: Placebo to Ramipril

Drug: Aliskiren

Ramipril

Active Comparator group

Description:

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.

Treatment:

Other: Placebo to Aliskiren

Drug: Ramipril