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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00631917

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren Drug: Ramipril	Phase IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Ramipril Aliskiren

U.S. FDA Resources

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

Further study details as provided by Novartis:

Primary Outcome Measures:

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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
To evaluate the overall gastrointestinal tolerability following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	640
Study Start Date:	February 2008
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Aliskiren 150mg, or 300mg, oral, once per day.	Drug: Aliskiren Aliskiren 150mg, or 300mg, oral, once per day.
2: Active Comparator Ramipril 5mg, or 10 mg, oral, once per day	Drug: Ramipril Ramipril 5mg, or 10 mg, oral, once per day

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631917

Locations

United States, Missouri
Investigative Site
Kansas City, Missouri, United States
Argentina
Investigative Site
Investigative Site, Argentina
Colombia
Investigative Site
Investigative Site, Colombia
France
Investigative Site
Investigative Site, France
Germany
Investigative Site
Investigative Site, Germany
India
Investigative Site
investigative Site, India
Peru
Investigative Site
Investigative Site, Peru
Spain
Investigative Site
Investigative Site, Spain

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

862-778-8300

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CSPP100A2404
Study First Received:	March 3, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00631917
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension,aliskiren, ramipril, colonoscopy

Study placed in the following topic categories:

Vascular Diseases
Essential hypertension
Ramipril
Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009