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

CompletadoFase 4ClinicalTrials.gov

ID: NCT00631917Tipo: INTERVENTIONALInicio: 1 de feb de 2008Fin estimado: 1 de sept de 2009

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

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).

Criterios de exclusión

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.

Intervenciones

drug

Aliskiren

Aliskiren 300 mg once a day

drug

Ramipril

Ramipril 10 mg once a day

other

Placebo to Ramipril

Placebo capsules to match ramipril.

other

Placebo to Aliskiren

Placebo tablets to match aliskiren.

Ubicaciones

Investigative Site

Investigative Site, Argentina

Patrocinadores

PrincipalNovartis

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