NCT00459004

Brief Summary

The primary objective is to verify the dose-response relationship of rimonabant on body weight change. The secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body weight loss and on secondary criteria associated with comorbidities, and to evaluate the safety and the pharmacokinetics of SR141716.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
527

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
Last Updated

April 7, 2009

Status Verified

April 1, 2009

Enrollment Period

1.5 years

First QC Date

April 10, 2007

Last Update Submit

April 6, 2009

Conditions

Obesity

Keywords

weight loss

Outcome Measures

Primary Outcomes (1)

  • absolute change in body weight from baseline to Week 24

Secondary Outcomes (3)

  • Efficacy: body weight, visceral fat area, waist circumference, fasting plasma glucose, HbA1c, triglyceride, HDL-cholesterol, blood pressure

  • Safety:adverse events, laboratory tests, ECGs

  • Pharmacokinetics: SR141716 plasma trough concentrations

Interventions

rimonabant (SR141716)DRUG

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index ≥25 kg/m²
  • Viceral Fat Area ≥ 100 cm²
  • Diet therapy for more than 8 weeks before start of the placebo observation period
  • Stable weight (variation \< ±3kg within 8 weeks before start of observation period)
  • At least 2 criteria of the following 3 comorbidities: Impaired Glucose Tolerance or Type 2 diabetes, Dyslipidemia (hypertriglyceridemia and/or low HDL-choresterol), Hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Tokyo, Japan

Location

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Rimonabant

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

PyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

Study Officials

  • Kohji SHIRAI, Professor

    Toho University Sakura Medical Center, Japan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 10, 2007

First Posted

April 11, 2007

Study Start

October 1, 2004

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

April 7, 2009

Record last verified: 2009-04

Locations

JP(1)