Japanese Dose-Response Study of Rimonabant in Obese Patients | NCT00459004

Studies
Japanese Dose-Response Study of Rimonabant in Obese Patients

NCT00459004

Sponsor

Sanofi

Status

Completed

Last Update Posted

Apr 7, 2009Estimated

Enrollment

527Actual

Phase

Phase 2

Conditions

Obesity

Interventions

rimonabant (SR141716)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Apr 2006Actual

Completion Date

Apr 2006Actual

First Submitted Date

Apr 10, 2007

First Submission Date that Met QC Criteria

Apr 10, 2007

First Posted Date

Apr 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2009

Last Update Posted Date

Apr 7, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

527Actual

Name	Type	Description	Arm Group Labels	Other Names
rimonabant (SR141716)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
absolute change in body weight from baseline to Week 24

Secondary Outcomes

Measure	Description	Time Frame
Efficacy: body weight, visceral fat area, waist circumference, fasting plasma glucose, HbA1c, triglyceride, HDL-cholesterol, blood pressure
Safety:adverse events, laboratory tests, ECGs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kohji SHIRAI, Professor	Toho University Sakura Medical Center, Japan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis		Tokyo			Japan

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D015431	Weight Loss

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077285	Rimonabant

Ancestor Terms

ID	Term
D011720	Pyrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided