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:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00678483
First received: May 13, 2008
Last updated: June 16, 2009
Last verified: June 2009
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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
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:
|
Obesity Weight Loss Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on June 18, 2013