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OpenTrials
Completed

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis, Shanghai, China

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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

rimonabant (SR141716)

Drug

Placebo

Drug

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).

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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