NCT Number: NCT00325546
Study of Weight-Reducing Effect and Safety of Rimonabant In Obesity in ASIA (RIO-ASIA)
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
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Sanofi-Aventis, Shanghai, China
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Placebo
DrugPrimary outcomes
-
Absolute change in weight from baseline to month 9
Secondary outcomes
-
HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference(physical examination, vital signs, ECG, laboratory tests, adverse events).
Interested in participating?
Looking for future studies?
Notify MeSponsors and collaborators
Lead sponsor
Sanofi
Industry
Registry information
Official study 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
Important dates
- Study start
- 2006
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- May 15, 2006
- Registry last updated
- Apr 7, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Evaluation of Patient Coach Support for Older Adults With Obesity
NCT06624163
Body Weight, Nutrition Disorders
Ann Arbor, Michigan, United States
View Trial DetailsA Clinical Study Comparing Semaglutide Injection and Wegovy® for Weight Management in Obese Subjects
NCT06738979
Body Weight, Nutrition Disorders
Hefei, Anhui, China
View Trial DetailsEffect Of The Use Of Navigation In The Alignment Obtained When Performing A Total Knee Arthroplasty In Obese Patients
NCT03865524
Arthritis, Arthropathy of Knee
Madrid, Spain
View Trial DetailsAngiotensin-(1-7) and Energy Expenditure in Human Obesity
NCT03777215
Body Weight, Nutrition Disorders
Hershey, Pennsylvania, United States
View Trial Details