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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

774 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

Aliskiren 300 mg once a day

Placebo to Ramipril

Intervention Type OTHER

Placebo capsules to match ramipril.

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.

Group Type ACTIVE_COMPARATOR

Ramipril

Intervention Type DRUG

Ramipril 10 mg once a day

Placebo to Aliskiren

Intervention Type OTHER

Placebo tablets to match aliskiren.

Interventions

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Aliskiren

Aliskiren 300 mg once a day

Intervention Type DRUG

Ramipril

Ramipril 10 mg once a day

Intervention Type DRUG

Placebo to Ramipril

Placebo capsules to match ramipril.

Intervention Type OTHER

Placebo to Aliskiren

Placebo tablets to match aliskiren.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No