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

Primary Purpose

Obesity, Weight Loss

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rimonabant (SR141716)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Cholesterol, HDL, triglycerides, insulin, blood glucose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi- Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

10 mg

20 mg

Outcomes

Primary Outcome Measures

The primary endpoint is the change in weight from baseline to 12 months

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
Safety : Vital signs, adverse events, laboratory tests

Full Information

First Posted
May 13, 2008
Last Updated
June 16, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00678483
Brief Title
Long-Term Effect of 10 mg Versus 20 mg Rimonabant in Overweight or Obese Patients
Acronym
MODERATO
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Terminated
Why Stopped
Company decision taken in light of demands by certain national health authorities
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Cholesterol, HDL, triglycerides, insulin, blood glucose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
10 mg
Arm Title
2
Arm Type
Experimental
Arm Description
20 mg
Intervention Type
Drug
Intervention Name(s)
rimonabant (SR141716)
Intervention Description
once daily
Primary Outcome Measure Information:
Title
The primary endpoint is the change in weight from baseline to 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
Title
Safety : Vital signs, adverse events, laboratory tests
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Zagreb
Country
Croatia
Facility Name
Sanofi-Aventis Administrative Office
City
Helsinki
Country
Finland
Facility Name
Sanofi- Aventis Administrative Office
City
Budapest
Country
Hungary
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Bucuresti
Country
Romania

12. IPD Sharing Statement

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

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