ObesityPhase 3NCT00029861
Obese Patients With or Without Comorbidities (RIO-North America)
A Phase 3 study testing Rimonabant (SR141716) in people with Obesity and Weight Loss, run by Sanofi at 51 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Rimonabant (SR141716)
- How many people
- 3,045 participants
- Where
- 51 sitesin 2 countries
- Study dates
- Aug 2001to Apr 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
51 sites in 2 countries.
51 sites in 2 countries
United States47 sites
Lovelace Scientific Resources
Albuquerque, New Mexico, 87108
Medical Dietetics, Inc.
Atlanta, Georgia, 30339
Radiant Research
Austin, Texas, 78758
Pennington Center
Baton Rouge, Louisiana, 70808
South Dayton Research Associates
Beavercreek, Ohio, 45431
Radiant Research
Birmingham, Alabama, 35209
Center for Nutrition and Preventive Medicine
Charlotte, North Carolina, 28207
ClinSearch
Chattanooga, Tennessee, 37404
Lindner Clinical Trials Center
Cincinnati, Ohio, 45219
Radiant Research
Columbus, Ohio, 43212
East Bay Clinical Trial Center
Concord, California, 94520
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230
Endocrinology and Diabetes Consultants, PC
Dover, New Hampshire, 03820
Ranch View Family Medicine
Highlands Ranch, Colorado, 80130
nTouch Research
Houston, Texas, 77024
Medical Research Consortium
Indianapolis, Indiana, 46208
Radiant Research
Lawrenceville, New Jersey, 08648
University of KY Internal Medicine
Lexington, Kentucky, 40536-9841
Longmont Medical Research Network
Longmont, Colorado, 80501
Clinical Nutrition Clinic, University of Wisconsin
Madison, Wisconsin, 53705
Central New York Clinical Research
Manlius, New York, 13104
Miami Research Associates
Miami, Florida, 33173
Montana Medical Research, LLC
Missoula, Montana, 59804
Anchor Research Center
Naples, Florida, 34102
Clinical Research Associates, Inc
Nashville, Tennessee, 37203
Comprehensive Weight Control Program
New York, New York, 10021
St. Luke's Roosevelt Hospital Center
New York, New York, 10025
Health Core, Inc.
Newark, Delaware, 19713
Central Florida Clinical Solutions
Ocoee, Florida, 34761
Orlando Clinical Research Center
Orlando, Florida, 32806
Radiant Research
Phoenix, Arizona, 85013
Radiant Research
Portland, Oregon, 97201
Multi-Specialty Research Associates of North Carolina
Raleigh, North Carolina, 27609
Rainer Clinical Research Center, Inc.
Renton, Washington, 98055-5704
Commonwealth Clinical Research Specialists (CCRS)
Richmond, Virginia, 23226
Advanced Clinical Research
Salt Lake City, Utah, 84102
Quality Research, Inc.
San Antonio, Texas, 78209
Feighner Research Institute
San Diego, California, 92121
Scripps Clinic
San Diego, California, 92130
SFM Clinical Trials
Scotland, Pennsylvania, 17254
Springfield Diabetes and Endocrine Center
Springfield, Illinois, 62704
JM Clinical Trials, Inc.
Swansea, Massachusetts, 02777
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
George Washington Univ. Wieght Mmgt Program
Washington D.C., District of Columbia, 20037
Palm Beach Research Center
West Palm Beach, Florida, 33409
Wichita Clinic, PA
Wichita, Kansas, 67208
Radiant Research
Wyomissing, Pennsylvania, 19610
Canada4 sites
Corunna Medical Clinic
Corunna, Ontario, N0N1G0
Quarry Family Medicine Clinic
Kingston, Ontario, K7L3E4
Trial Management Group
Richmond Hill, Ontario, L4E3S8
Group North
Windsor, Ontario, N8X3V6
About this study
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
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
- Conditions
- Obesity, Weight Loss
- Being tested
- Rimonabant (SR141716)
- Keywords
- Weight Loss, Obesity, Weight Reduction, Overweight
- Medical subject headings
- Obesity, Weight Loss, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimonabant (SR141716)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Secondary outcomes (1)
Metabolic parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2002 (estimated)
- Study startAug 2001
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029861
- Sponsor's protocol ID
- EFC4743
- Status last verified
- Apr 2009
- First submitted
- 23 Jan 2002
- Last updated
- 20 Apr 2009
- Results posted
- No
Publications
Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin J, Rosenstock J; RIO-North America Study Group. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomized controlled trial. JAMA. 2006 Feb 15;295(7):761-75. doi: 10.1001/jama.295.7.761.
PubMed 16478899
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00029861
- Acronym / sponsor ID
- EFC4743
- Conditions
- Obesity, Weight Loss
- Keywords
- Weight Loss, Obesity, Weight Reduction, Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,045 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 24 Jan 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rimonabant (SR141716) | Drug | – |
Primary outcome
Change in body weight
1 secondary outcome
Metabolic parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2009.
- Results publication: PubMed 16478899Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin J, Rosenstock J; RIO-North America Study Group. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomized controlled trial. JAMA. 2006 Feb 15;295(7):761-75. doi: 10.1001/jama.295.7.761.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
51 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimonabant (SR141716) in people with Obesity and Weight Loss, run by Sanofi at 51 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00029861, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2009.