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
1 other identifier
interventional
643
3 countries
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Apr 2006
Shorter than P25 for phase_3 obesity
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 12, 2006
CompletedFirst Posted
Study publicly available on registry
May 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedApril 7, 2009
April 1, 2009
1 year
May 12, 2006
April 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absolute change in weight from baseline to month 9
Secondary Outcomes (1)
HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference(physical examination, vital signs, ECG, laboratory tests, adverse events).
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index (BMI)\> 25 kg/m²
You may not qualify if:
- 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,
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (3)
Sanofi-Aventis
Shanghai, 200040, China
Sanofi-Aventis
Seoul, 135-755, South Korea
Sanofi-Aventis
Taipei, 105, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 12, 2006
First Posted
May 15, 2006
Study Start
April 1, 2006
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
April 7, 2009
Record last verified: 2009-04