ObesityPhase 3PRADONCT00405808
Rimonabant in Abdominally Obese Patients With Impaired Fasting Blood Glucose
A Phase 3 study testing Rimonabant in people with Obesity, run by Sanofi at 27 sites in 27 countries.
Trial summary
Primary objective: To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Rimonabant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,666 participants
- Where
- 27 sitesin 27 countries
- Study dates
- Dec 2006to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥ 30Kg/m², or > 27kg/m² if associated with risk factor(s) such as dyslipidemia, and < 40kg/m²,
- Waist Circumference > 88 cm in women; > 102 cm in men,
- Confirmed (by at least 2 measurements) impaired Fasting Plasma Glucose (FPG ≥ 100 mg/dl (5.6 mmol/L) and < 126 mg/dl (7.0 mmol/L) in non diabetic patients,
- LDL cholesterol up to 155 mg/dl (4.00 mmol/L) including patients on a stable dose of statin therapy for at least 8 weeks prior to screening,
- Current treatment with statins and/or ezetimibe and/or antihypertensive therapy must be at fixed and stable dose for at least 8 weeks prior to screening visit,
- Patients, who are willing and in the opinion of the Investigator safely assumed to remain on stable and fixed doses of antihypertensive, and/or statins and/or ezetimibe without adding additional medications or changing current treatment for the duration of the trial.
Who cannot join
- Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed (excluded by pregnancy test),
- Absence of medically approved contraceptive methods for female of childbearing potential,
- History of very low-calorie diet within 3 months prior to screening visit (lower than 1200 Kcal/day),
- Weight change > 5 kg within 3 months prior to screening visit,
- History of surgical procedures for weight loss (e.g., stomach stapling, bypass),
- History of bulimia or anorexia nervosa as per DSM-IV criteria,
Show all 33Show fewer
- Presence of any clinically significant endocrine disease according to the investigator, in particular known abnormal TSH and free T4 blood level (Patients treated with thyroid replacement therapy must be on fixed and stable dose for at least 3 months prior to screening and must be in euthyroïd status),
- Established type 1 or 2 diabetes treated, or with at least 2 measures of fasting blood glucose ≥ 126 mg/dl /L,
- Triglyceride level > 400 mg/dL (4.52 mmol),
- Systolic blood pressure > 160 mm Hg or diastolic blood pressure >100 mmHg at screening visit,
- Known severe renal dysfunction (creatinine clearance < 30 ml/min) or nephrotic syndrome or urinalysis (performed at screening by dipstick) showing 2+ or more protein,
- Known severe hepatic impairment or AST and/or ALT > 3 times the upper limit of normal at screening,
- Presence of any condition (medical, including clinically significant abnormal laboratory tests, psychological, social or geographical) actual or anticipated that the investigator feels would compromise the patient's safety or limit his/her successful participation to the study. In particular :
- Cardiac abnormalities: cardiac failure status NYHA III or IV, relevant acute abnormal finding seen on ECG at screening or within 6 months before screening,
- Any current malignancy or any cancer within the past five years (except adequately treated basal cell skin cancer or cervix carcinoma in situ),
- Significant haematology abnormalities (haemoglobin < 100 g/L and/or neutrophils < 1.5 G/L and/or platelets < 100 G/L),
- Acute psychiatric disorders or mental condition which could interfere with the patient's compliance or safe participation in the study,
- Patient treated for epilepsy,
- Ongoing major depressive illness,
- Uncontrolled psychiatric illness,
- History of alcohol or other substance abuse,
- Hypersensitivity /intolerance to the active substance or to any of the excipients such as lactose,
- Administration of any investigational treatment (drug or device) within 30 days prior to screening,
- Previous participation in a Rimonabant study or previous administration of Rimonabant,
- Administration of any of the following within 3 months prior to screening visit:
- Anti obesity drugs (eg, sibutramine, orlistat),
- Other drugs for weight reduction (phentermine, amphetamines),
- Herbal preparations for weight reduction,
- Nicotinic acid, fibrates or bile acid sequestrants ,
- Prolonged use (more than one week) of systemic corticosteroids, neuroleptics.
- Omega-3 fatty acid approved medication
- Ongoing antidepressive treatment(including bupropion)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
27 sites in 27 countries.
27 sites in 27 countries
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford Surrey
About this study
Official title: A Pan-European Randomized, Parallel Group, Two-arm Placebo-controlled, Double-blind Multicenter Study of Rimonabant 20mg Once Daily in the Treatment of Abdominally Obese Patients With Impaired Fasting Blood Glucose With or Without Other Comorbidities
Primary objective:
To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose and with or without associated comorbidities.
Main Secondary objectives:
To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic parameters and lipid parameters.
To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.
- Conditions
- Obesity
- Being tested
- Rimonabant, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimonabantDrug
Once daily in the morning
PlaceboDrug
Once daily in the morning
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Administration of one tablet containing 20 mg of Rimonabant Receives: Drug: Rimonabant |
| 2 | Placebo comparator | Administration of one Rimonabant placebo tablet. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the co-primary endpoint : FPG, HDL-C and triglyceride levels.
Measured: From baseline to end of treatment
Secondary outcomes (5)
Waist circumference and body weight
Measured: At each visit
Glycemic parameters (FPG, fasting insulinemia, HbA1c), lipid parameters (Total Cholesterol, HDL-C, LDL-C, triglyceride levels), inflammatory parameter (Hs-CRP),
Measured: All these laboratory parameters will be measured prior to baseline, month 3, month 6 and month 12.
Quality of life (IWQOL questionnaire completion)
Measured: At baseline, month 3, month 6, month 9 and month 12
Incidence of adverse events in each group, including neuro-psychiatric adverse events
Measured: From the signature of the ICF to the end of the study
Standard laboratory assessments
Measured: Prior to baseline and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startDec 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: EMEA recommendation to suspend Acomplia marketing authorisation
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,666 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Valérie Pilorget, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405808
- Sponsor's protocol ID
- RIMON_R_00961
- Other IDs
- EUDRACT # : 2006-001711-30
- Acronym
- PRADO
- Status last verified
- Jan 2011
- First submitted
- 28 Nov 2006
- Last updated
- 26 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pan-European Randomized, Parallel Group, Two-arm Placebo-controlled, Double-blind Multicenter Study of Rimonabant 20mg Once Daily in the Treatment of Abdominally Obese Patients With Impaired Fasting Blood Glucose With or Without Other Comorbidities
- ClinicalTrials.gov ID
- NCT00405808
- Acronym / sponsor ID
- PRADO / RIMON_R_00961
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: EMEA recommendation to suspend Acomplia marketing authorisation
- Enrolment
- 2,666 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 30 Nov 2006 (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.
Primary objective:
To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose and with or without associated comorbidities.
Main Secondary objectives:
To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic parameters and lipid parameters.
To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RimonabantAdministration of one tablet containing 20 mg of Rimonabant |
| 2 | Placebo comparator | Drug: PlaceboAdministration of one Rimonabant placebo tablet. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI ≥ 30Kg/m², or > 27kg/m² if associated with risk factor(s) such as dyslipidemia, and < 40kg/m²,
- Waist Circumference > 88 cm in women; > 102 cm in men,
- Confirmed (by at least 2 measurements) impaired Fasting Plasma Glucose (FPG ≥ 100 mg/dl (5.6 mmol/L) and < 126 mg/dl (7.0 mmol/L) in non diabetic patients,
- LDL cholesterol up to 155 mg/dl (4.00 mmol/L) including patients on a stable dose of statin therapy for at least 8 weeks prior to screening,
- Current treatment with statins and/or ezetimibe and/or antihypertensive therapy must be at fixed and stable dose for at least 8 weeks prior to screening visit,
Key exclusion criteria (33 listed)
- Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed (excluded by pregnancy test),
- Absence of medically approved contraceptive methods for female of childbearing potential,
- History of very low-calorie diet within 3 months prior to screening visit (lower than 1200 Kcal/day),
- Weight change > 5 kg within 3 months prior to screening visit,
- History of surgical procedures for weight loss (e.g., stomach stapling, bypass),
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 |
|---|---|---|
| RimonabantOnce daily in the morning | Drug | 1 |
| PlaceboOnce daily in the morning | Drug | 2 |
Primary outcome
Mean change in the co-primary endpoint : FPG, HDL-C and triglyceride levels.
Time frame: From baseline to end of treatment
5 secondary outcomes
Waist circumference and body weight
Time frame: At each visit
Glycemic parameters (FPG, fasting insulinemia, HbA1c), lipid parameters (Total Cholesterol, HDL-C, LDL-C, triglyceride levels), inflammatory parameter (Hs-CRP),
Time frame: All these laboratory parameters will be measured prior to baseline, month 3, month 6 and month 12.
Quality of life (IWQOL questionnaire completion)
Time frame: At baseline, month 3, month 6, month 9 and month 12
Incidence of adverse events in each group, including neuro-psychiatric adverse events
Time frame: From the signature of the ICF to the end of the study
Standard laboratory assessments
Time frame: Prior to baseline and month 12
Results and safety
The study was stopped early (reason given: EMEA recommendation to suspend Acomplia marketing authorisation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2011.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Valérie Pilorget, MD study director
Sanofi
27 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimonabant in people with Obesity, run by Sanofi at 27 sites in 27 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 6 inclusion and 33 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 26 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Austria, Belgium, Brazil, Bulgaria, Canada and 22 more countries. 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. Some participants in this study may receive a placebo. 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: EMEA recommendation to suspend Acomplia marketing authorisation). 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?
Mean change in the co-primary endpoint : FPG, HDL-C and triglyceride levels. (time frame: From baseline to end of treatment). 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 26 Jan 2011.