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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Obesity	Drug: Rimonabant (SR141716); Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	643 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	April 2006
Actual Primary Completion Date :	April 2007
Actual Study Completion Date :	April 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Absolute change in weight from baseline to month 9

Secondary Outcome Measures :

1. HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference(physical examination, vital signs, ECG, laboratory tests, adverse events).

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

China
Sanofi-Aventis
Shangai, China, 200040
Korea, Republic of
Sanofi-Aventis
Seoul, Korea, Republic of, 135-755
Taiwan
Sanofi-Aventis
Taipei, Taiwan, 105

Sponsors and Collaborators

Sanofi

Investigators

Study Director:	ICD CSD	Sanofi

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00325546 History of Changes
Other Study ID Numbers:	EFC6001
First Posted:	May 15, 2006
Last Update Posted:	April 7, 2009
Last Verified:	April 2009

Keywords provided by Sanofi:

Obesity

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms; Rimonabant	Cannabinoid Receptor Antagonists; Cannabinoid Receptor Modulators; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs