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

Condition(s) targeted: Hypertension

Intervention: Aliskiren (Drug); Ramipril (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: 862-778-8300

Overall contact:
Novartis, Phone: 862-778-8300

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.

Official 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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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

Secondary outcome:

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

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.

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.

To evaluate the overall gastrointestinal tolerability following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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.

Novartis, Phone: 862-778-8300

Investigative Site, Investigative Site, Argentina; Not yet recruiting
Novartis
Phone: 862-778-8300

Investigative Site, Investigative Site, Colombia; Not yet recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Investigative Site, France; Not yet recruiting
Novartis
Phone: 41 61 324 1111

Investigative Site, Investigative Site, Germany; Not yet recruiting
Novatis
41 61 324 1111

Investigative Site, investigative Site, India; Not yet recruiting
Novartis
Phone: 41 61 324 1111

Investigative Site, Investigative Site, Peru; Not yet recruiting
Novartis
Phone: 862-778-8300

Investigative Site, Investigative Site, Spain; Not yet recruiting
Novartis
Phone: 41 61 324 1111

Investigative Site, Kansas City, Missouri, United States; Recruiting
Phone: 862-778-8300

Starting date: February 2008
Last updated: March 7, 2008