NCT00481923

Brief Summary

The primary objective of this study is to assess the effect of rimonabant on the energy intake (kcal/day/meal) from ad-libitum high-fat dinner (primary endpoint), pre- and post-ingestive responses, and the hedonic evaluation of food, and its effect on food choice, cravings and feelings of control. The secondary objectives are to determine the effect of rimonabant on body weight with or without hypocaloric diet and its clinical and laboratory safety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P25-P50 for phase_3 obesity

Timeline
Completed

Started May 2004

Shorter than P25 for phase_3 obesity

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

May 1, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2007

Completed
Last Updated

April 20, 2009

Status Verified

April 1, 2009

Enrollment Period

11 months

First QC Date

June 1, 2007

Last Update Submit

April 17, 2009

Conditions

Obesity

Keywords

hypocaloric dietenergy intake

Outcome Measures

Primary Outcomes (1)

  • Absolute change from baseline in energy intake during ad-libitum dinner of the high-fat probe day at Weeks 3/4 of double-blind treatment.

Secondary Outcomes (2)

  • Satiety, food choice, feeling of control, craving using a series of rating scales during the probe and/or "free-living" days

  • Clinical Safety

Interventions

rimonabant (SR141716)DRUG

Eligibility Criteria

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

You may qualify if:

  • Obese subjects with Body Mass Index ≥ 30 and \< 45 kg/m²
  • The above information is not intended 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 (1)

Sanofi-Aventis Administrative Office

Guildford, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Interventions

Rimonabant

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

Study Officials

  • John Blundell, Pr

    University of Leeds, United Kingdom

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 1, 2007

First Posted

June 4, 2007

Study Start

May 1, 2004

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

April 20, 2009

Record last verified: 2009-04

Locations

GB(1)