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
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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).
Sponsors 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.
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