Obese Patients With or Without Comorbidities (RIO-North America)

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00029861

Collaborator

(none)

3,045

Enrollment

Locations

Duration (Months)

59.7

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the effects of weight loss and weight maintenance over a period of two years when prescribed with a hypocaloric diet in obese patients with or without comorbidities

Condition or Disease	Intervention/Treatment	Phase
Obesity Weight Loss	Drug: Rimonabant (SR141716)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

3045 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing and Prevention of Weight Regain Effects and Safety in Obese Patients With or Without Comorbidities

Study Start Date :

Aug 1, 2001

Actual Primary Completion Date :

Apr 1, 2004

Actual Study Completion Date :

Apr 1, 2004

Outcome Measures

Primary Outcome Measures

Change in body weight []

Secondary Outcome Measures

Metabolic parameters []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Stable weight (variation of less than 5 kg within 3 months prior to screening visit)
BMI (Body Mass Index) of 30 or greater in patients with or without comorbidities, or BMI greater than 27 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiant Research	Birmingham	Alabama	United States	35209
2	Radiant Research	Phoenix	Arizona	United States	85013
3	East Bay Clinical Trial Center	Concord	California	United States	94520
4	Feighner Research Institute	San Diego	California	United States	92121
5	Scripps Clinic	San Diego	California	United States	92130
6	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
7	Ranch View Family Medicine	Highlands Ranch	Colorado	United States	80130
8	Longmont Medical Research Network	Longmont	Colorado	United States	80501
9	Health Core, Inc.	Newark	Delaware	United States	19713
10	George Washington Univ. Wieght Mmgt Program	Washington	District of Columbia	United States	20037
11	Miami Research Associates	Miami	Florida	United States	33173
12	Anchor Research Center	Naples	Florida	United States	34102
13	Central Florida Clinical Solutions	Ocoee	Florida	United States	34761
14	Orlando Clinical Research Center	Orlando	Florida	United States	32806
15	Palm Beach Research Center	West Palm Beach	Florida	United States	33409
16	Medical Dietetics, Inc.	Atlanta	Georgia	United States	30339
17	Springfield Diabetes and Endocrine Center	Springfield	Illinois	United States	62704
18	Medical Research Consortium	Indianapolis	Indiana	United States	46208
19	Wichita Clinic, PA	Wichita	Kansas	United States	67208
20	University of KY Internal Medicine	Lexington	Kentucky	United States	40536-9841
21	Pennington Center	Baton Rouge	Louisiana	United States	70808
22	JM Clinical Trials, Inc.	Swansea	Massachusetts	United States	02777
23	Montana Medical Research, LLC	Missoula	Montana	United States	59804
24	Endocrinology and Diabetes Consultants, PC	Dover	New Hampshire	United States	03820
25	Radiant Research	Lawrenceville	New Jersey	United States	08648
26	Lovelace Scientific Resources	Albuquerque	New Mexico	United States	87108
27	Central New York Clinical Research	Manlius	New York	United States	13104
28	Comprehensive Weight Control Program	New York	New York	United States	10021
29	St. Luke's Roosevelt Hospital Center	New York	New York	United States	10025
30	Center for Nutrition and Preventive Medicine	Charlotte	North Carolina	United States	28207
31	Multi-Specialty Research Associates of North Carolina	Raleigh	North Carolina	United States	27609
32	South Dayton Research Associates	Beavercreek	Ohio	United States	45431
33	Lindner Clinical Trials Center	Cincinnati	Ohio	United States	45219
34	Radiant Research	Columbus	Ohio	United States	43212
35	Radiant Research	Portland	Oregon	United States	97201
36	SFM Clinical Trials	Scotland	Pennsylvania	United States	17254
37	Radiant Research	Wyomissing	Pennsylvania	United States	19610
38	ClinSearch	Chattanooga	Tennessee	United States	37404
39	Clinical Research Associates, Inc	Nashville	Tennessee	United States	37203
40	Radiant Research	Austin	Texas	United States	78758
41	Dallas Diabetes and Endocrine Center	Dallas	Texas	United States	75230
42	nTouch Research	Houston	Texas	United States	77024
43	Quality Research, Inc.	San Antonio	Texas	United States	78209
44	Advanced Clinical Research	Salt Lake City	Utah	United States	84102
45	Commonwealth Clinical Research Specialists (CCRS)	Richmond	Virginia	United States	23226
46	Rainer Clinical Research Center, Inc.	Renton	Washington	United States	98055-5704
47	Clinical Nutrition Clinic, University of Wisconsin	Madison	Wisconsin	United States	53705
48	Corunna Medical Clinic	Corunna	Ontario	Canada	N0N1G0
49	Quarry Family Medicine Clinic	Kingston	Ontario	Canada	K7L3E4
50	Trial Management Group	Richmond Hill	Ontario	Canada	L4E3S8
51	Group North	Windsor	Ontario	Canada	N8X3V6