NCT00678483

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
331

participants targeted

Target at P50-P75 for phase_3 obesity

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_3 obesity

Geographic Reach
5 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

June 17, 2009

Status Verified

June 1, 2009

Enrollment Period

7 months

First QC Date

May 13, 2008

Last Update Submit

June 16, 2009

Conditions

ObesityWeight Loss

Keywords

CholesterolHDLtriglyceridesinsulinblood glucose

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (2)

  • 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

    12 months

  • Safety : Vital signs, adverse events, laboratory tests

    12 months

Study Arms (2)

1

EXPERIMENTAL

10 mg

Drug: rimonabant (SR141716)

2

EXPERIMENTAL

20 mg

Drug: rimonabant (SR141716)

Interventions

rimonabant (SR141716)DRUG

once daily

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sanofi-Aventis Administrative Office

Zagreb, Croatia

Location

Sanofi-Aventis Administrative Office

Helsinki, Finland

Location

Sanofi- Aventis Administrative Office

Budapest, Hungary

Location

Sanofi-Aventis Administrative Office

Gouda, Netherlands

Location

Sanofi-Aventis Administrative Office

Bucharest, Romania

Location

MeSH Terms

Conditions

ObesityWeight LossInsulin Resistance

Interventions

Rimonabant

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

PyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

Study Officials

  • ICD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 13, 2008

First Posted

May 15, 2008

Study Start

April 1, 2008

Primary Completion

November 1, 2008

Study Completion

February 1, 2009

Last Updated

June 17, 2009

Record last verified: 2009-06

Locations

RO(1)CR(1)FI(1)HU(1)NL(1)