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Long-Term Effect of 10 mg Versus 20 mg Rimonabant in Overweight or Obese Patients (MODERATO)

This study has been terminated.
(Company decision taken in light of demands by certain national health authorities)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00678483
First received: May 13, 2008
Last updated: June 16, 2009
Last verified: June 2009
  Purpose

The primary objective of this study is to assess, over a period of 12 months, the effect on weight loss and weight maintenance of rimonabant 10 mg in comparison with rimonabant 20 mg in overweight/obese patients after an initial treatment period of 6 months with rimonabant 20 mg.

Secondary objectives are to assess the effect of rimonabant over a period of 12 months on waist circumference, high-density lipoprotein (HDL)-Cholesterol and triglycerides (TG), fasting plasma glucose (FPG), fasting insulin and to evaluate the long-term safety and tolerability of rimonabant 10 mg and 20 mg over a period of 12 months after randomization in overweight/obese patients.


Condition Intervention Phase
Obesity
Weight Loss
Drug: rimonabant (SR141716)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess the Long-Term Effect, Over 1 Year, of Rimonabant 10 mg in Comparison With Rimonabant 20 mg After an Initial Treatment Period of 6 Months With Rimonabant 20 mg in Overweight or Obese Patients

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The primary endpoint is the change in weight from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: - Absolute change in waist circumference from baseline - Relative change in HDL-Cholesterol and in Triglycerides from baseline - Absolute change in Fasting Plasma Glucose from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety : Vital signs, adverse events, laboratory tests [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 331
Study Start Date: April 2008
Study Completion Date: February 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
10 mg
Drug: rimonabant (SR141716)
once daily
Experimental: 2
20 mg
Drug: rimonabant (SR141716)
once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body Mass index (BMI) of at least 30 kg/m² or BMI >27 kg/m² with associated risk factors such as type 2 diabetes or dyslipidemia

Exclusion Criteria:

  • Weight loss > 5 kg within 3 months prior to screening Visit.
  • Presence of any clinically significant endocrine disease including the presence of type 1 diabetes
  • Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders
  • Previous participation in a clinical study with rimonabant
  • Administration of other investigational drugs, anti-obesity drugs or other drugs for weight reduction
  • Pregnancy and absence of effective contraceptive method for females of childbearing potential
  • Exenatide
  • Insulin therapy
  • Recent change or need for change in the oral antidiabetic treatment
  • Recent change or need for change in the lipid lowering treatment
  • Presence of severe renal or hepatic impairment

The above information is not intented to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678483

Locations
Croatia
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
Hungary
Sanofi- Aventis Administrative Office
Budapest, Hungary
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Romania
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD Sanofi
  More Information

No publications provided

Responsible Party: ICD, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00678483     History of Changes
Other Study ID Numbers: EFC10139, EudraCT : 2007-002492-14
Study First Received: May 13, 2008
Last Updated: June 16, 2009
Health Authority: Romania: Ministry of Public Health
South Africa: Department of Health
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Sanofi:
Cholesterol
HDL
triglycerides
insulin
blood glucose

Additional relevant MeSH terms:
Overweight
Weight Loss
Body Weight
Body Weight Changes
Signs and Symptoms
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014