Obese Patients With or Without Comorbidities (RIO-North America)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Weight Loss; Obesity

Treatments: Drug: Rimonabant (SR141716)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00029861

EFC4743

Details and patient eligibility

About

To assess the effects of weight loss and weight maintenance over a period of two years when prescribed with a hypocaloric diet in obese patients with or without comorbidities

Enrollment: 3,045 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Stable weight (variation of less than 5 kg within 3 months prior to screening visit)
• BMI (Body Mass Index) of 30 or greater in patients with or without comorbidities, or BMI greater than 27 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind