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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

331 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

10 mg

Group Type EXPERIMENTAL

rimonabant (SR141716)

Intervention Type DRUG

once daily

2

20 mg

Group Type EXPERIMENTAL

rimonabant (SR141716)

Intervention Type DRUG

once daily

Interventions

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rimonabant (SR141716)

once daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No