ObesityPhase 3MODERATONCT00678483
Long-Term Effect of 10 mg Versus 20 mg Rimonabant in Overweight or Obese Patients
A Phase 3 study testing rimonabant (SR141716) in people with Obesity and Weight Loss, run by Sanofi at 5 sites in 5 countries.
Trial summary
The primary objective of this study is to assess, over a period of 12 months, the effect on weight loss and weight maintenance of rimonabant 10 mg in comparison with rimonabant 20 mg in overweight/obese patients after an initial treatment period of 6 months with rimonabant 20 mg. 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)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Apr 2008to Feb 2009
- 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
Who may be able to join
- Body Mass index (BMI) of at least 30 kg/m² or BMI >27 kg/m² with associated risk factors such as type 2 diabetes or dyslipidemia
Who cannot join
- Weight loss > 5 kg within 3 months prior to screening Visit.
- Presence of any clinically significant endocrine disease including the presence of type 1 diabetes
- Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders
- Previous participation in a clinical study with rimonabant
- Administration of other investigational drugs, anti-obesity drugs or other drugs for weight reduction
- Pregnancy and absence of effective contraceptive method for females of childbearing potential
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- Exenatide
- Insulin therapy
- Recent change or need for change in the oral antidiabetic treatment
- Recent change or need for change in the lipid lowering treatment
- Presence of severe renal or hepatic impairment
- The above information is not intented to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess the Long-Term Effect, Over 1 Year, of Rimonabant 10 mg in Comparison With Rimonabant 20 mg After an Initial Treatment Period of 6 Months With Rimonabant 20 mg in Overweight or Obese Patients
The primary objective of this study is to assess, over a period of 12 months, the effect on weight loss and weight maintenance of rimonabant 10 mg in comparison with rimonabant 20 mg in overweight/obese patients after an initial treatment period of 6 months with rimonabant 20 mg.
Secondary objectives are to assess the effect of rimonabant over a period of 12 months on waist circumference, high-density lipoprotein (HDL)-Cholesterol and triglycerides (TG), fasting plasma glucose (FPG), fasting insulin and to evaluate the long-term safety and tolerability of rimonabant 10 mg and 20 mg over a period of 12 months after randomization in overweight/obese patients.
- Conditions
- Obesity, Weight Loss
- Being tested
- rimonabant (SR141716)
- Keywords
- Cholesterol, HDL, triglycerides, insulin, blood glucose
- Medical subject headings
- Obesity, Weight Loss, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rimonabant (SR141716)Drug
once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 10 mg Receives: Drug: rimonabant (SR141716) |
| 2 | Experimental | 20 mg Receives: Drug: rimonabant (SR141716) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the change in weight from baseline to 12 months
Measured: 12 months
Secondary outcomes (2)
Efficacy: - Absolute change in waist circumference from baseline - Relative change in HDL-Cholesterol and in Triglycerides from baseline - Absolute change in Fasting Plasma Glucose from baseline
Measured: 12 months
Safety : Vital signs, adverse events, laboratory tests
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2008
- Study completionFeb 2009
Why it stopped: Company decision taken in light of demands by certain national health authorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678483
- Sponsor's protocol ID
- EFC10139
- Other IDs
- EudraCT : 2007-002492-14
- Acronym
- MODERATO
- Status last verified
- Jun 2009
- First submitted
- 13 May 2008
- Last updated
- 17 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess the Long-Term Effect, Over 1 Year, of Rimonabant 10 mg in Comparison With Rimonabant 20 mg After an Initial Treatment Period of 6 Months With Rimonabant 20 mg in Overweight or Obese Patients
- ClinicalTrials.gov ID
- NCT00678483
- Acronym / sponsor ID
- MODERATO / EFC10139
- Conditions
- Obesity, Weight Loss
- Keywords
- Cholesterol, HDL, triglycerides, insulin, blood glucose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision taken in light of demands by certain national health authorities
- Enrolment
- 331 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 15 May 2008 (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.
The primary objective of this study is to assess, over a period of 12 months, the effect on weight loss and weight maintenance of rimonabant 10 mg in comparison with rimonabant 20 mg in overweight/obese patients after an initial treatment period of 6 months with rimonabant 20 mg.
Secondary objectives are to assess the effect of rimonabant over a period of 12 months on waist circumference, high-density lipoprotein (HDL)-Cholesterol and triglycerides (TG), fasting plasma glucose (FPG), fasting insulin and to evaluate the long-term safety and tolerability of rimonabant 10 mg and 20 mg over a period of 12 months after randomization in overweight/obese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: rimonabant (SR141716)10 mg |
| 2 | Experimental | Drug: rimonabant (SR141716)20 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body Mass index (BMI) of at least 30 kg/m² or BMI >27 kg/m² with associated risk factors such as type 2 diabetes or dyslipidemia
Key exclusion criteria (12 listed)
- Weight loss > 5 kg within 3 months prior to screening Visit.
- Presence of any clinically significant endocrine disease including the presence of type 1 diabetes
- Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders
- Previous participation in a clinical study with rimonabant
- Administration of other investigational drugs, anti-obesity drugs or other drugs for weight reduction
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)once daily | Drug | 1, 2 |
Primary outcome
The primary endpoint is the change in weight from baseline to 12 months
Time frame: 12 months
2 secondary outcomes
Efficacy: - Absolute change in waist circumference from baseline - Relative change in HDL-Cholesterol and in Triglycerides from baseline - Absolute change in Fasting Plasma Glucose from baseline
Time frame: 12 months
Safety : Vital signs, adverse events, laboratory tests
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Company decision taken in light of demands by certain national health authorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2009.
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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 study director
Sanofi
5 sites in 5 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 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. 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: stopped early, as of the sponsor's last update on 17 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Croatia, Finland, Hungary, Netherlands, Romania. 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 was stopped early (reason given: Company decision taken in light of demands by certain national health authorities). Results are not available in the source record.
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?
The primary endpoint is the change in weight from baseline to 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2009.