Study of Weight-Reducing Effect and Safety of Rimonabant In Obesity in ASIA (RIO-ASIA)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose (Rimonabant 20mg), Multi-National, Multicentre Study of Weight-Reducing Effect and Safety of Rimonabant in Obese Patients With or Without Comorbidities

Patrocinadores

Patrocinador principal: Sanofi

Fuente Sanofi
Resumen breve

Primary : effect on weight loss and weight maintenance over 9 months when prescribed with a hypocaloric diet in obese patients.

Secondary : effect on HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference - safety and tolerability

Estado general Completed
Fecha de inicio April 2006
Fecha de Terminación April 2007
Fecha de finalización primaria April 2007
Fase Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Absolute change in weight from baseline to month 9
Resultado secundario
Medida Periodo de tiempo
HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference(physical examination, vital signs, ECG, laboratory tests, adverse events).
Inscripción 643
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Rimonabant (SR141716)

Tipo de intervención: Drug

Nombre de intervención: Placebo

Elegibilidad

Criterios:

Inclusion Criteria:

- Body mass index (BMI)> 25 kg/m²

Exclusion Criteria:

- Absence of stable weight (variation < 5 kg) within three months prior to screening visit),

- Absence of effective contraceptive method for females of childbearing potential,

- Presence of treated or untreated type 1 or type 2 diabetes,

- Systolic blood pressure > 165 mm Hg and/or diastolic blood pressure > 105 mm Hg on 2 consecutive visits from the screening to the inclusion visit,

- Presence of secondary hypertension,

- Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint (presence of any clinically significant endocrine disease according to the Investigator, obesity of known endocrine origin...)

- Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study,

- Presence of any clinically significant abnormality according to the Investigator on the ECG performed on the inclusion visit.

- Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.

- Related to previous or concomitant medications :

- Drugs affecting weight (e.g., sibutramine, orlistat, herbal preparations, etc).

- Antidiabetic drugs.

- Related to laboratory findings:

- Positive test for hepatitis B surface antigen and/or hepatitis C antibody.

- Abnormal TSH level (TSH > ULN or < LLN).

- Positive urine pregnancy test.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
ICD CSD Study Director Sanofi
Ubicación
Instalaciones:
Sanofi-Aventis | Shangai, 200040, China
Sanofi-Aventis | Seoul, 135-755, Korea, Republic of
Sanofi-Aventis | Taipei, 105, Taiwan
Ubicacion Paises

China

Korea, Republic of

Taiwan

Fecha de verificación

April 2009

Fiesta responsable

Nombre Titulo: ICD Study Director

Organización: sanofi-aventis

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov