Clinical trial NCT00631917: A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension, aliskiren, ramipril, colonoscopy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-03-10
Enrollment: 774
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Colonic Pathology
timeFrame: 54 weeks
measure: Summary of the End of Study Colonoscopy Results
timeFrame: 54 weeks
Secondary outcomes:
measure: Percentage of Participants With Each of the Individual Components of Colonic Pathology
timeFrame: 54 weeks
measure: Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment
timeFrame: 54 weeks
measure: Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target
timeFrame: Weeks 8, 30 and End of Study (54 weeks)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Investigative Site
state: Missouri
city: Investigative Site
country: Argentina
facility: Investigative Site
city: Investigative Site
country: Colombia
facility: Investigative Site
city: Investigative Site
country: France
facility: Investigative Site
city: Investigative Site
country: Germany
facility: Investigative Site
city: investigative Site
country: India
facility: Investigative Site
city: Investigative Site
country: Spain
facility: Investigative Site
Study officials:
affiliation: 862-778-8300
name: Novartis
role: STUDY_CHAIR
References:
citation: Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.