Study of Weight-Reducing Effect and Safety of Rimonabant In Obesity in ASIA (RIO-ASIA)
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ClinicalTrials.gov Identifier: NCT00325546 |
Recruitment Status
:
Completed
First Posted
: May 15, 2006
Last Update Posted
: April 7, 2009
|
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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 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 |

- Absolute change in weight from baseline to month 9
- HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference(physical examination, vital signs, ECG, laboratory tests, adverse events).

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325546
China | |
Sanofi-Aventis | |
Shangai, China, 200040 | |
Korea, Republic of | |
Sanofi-Aventis | |
Seoul, Korea, Republic of, 135-755 | |
Taiwan | |
Sanofi-Aventis | |
Taipei, Taiwan, 105 |
Study Director: | ICD CSD | Sanofi |
Responsible Party: | ICD Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00325546 History of Changes |
Other Study ID Numbers: |
EFC6001 |
First Posted: | May 15, 2006 Key Record Dates |
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 |