ObesityPhase 3ETERNALNCT00412698
European Trial About Effect of RimoNabant on Abdominal Obese Patients With dysLipidemia
A Phase 3 study testing rimonabant in people with Obesity and Dyslipidemias, run by Sanofi at 15 sites in 15 countries.
Trial summary
Primary : To determine the effect of Rimonabant 20 mg on changes in, HDL-Cholesterol (HDL-C), triglyceride levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with dyslipidemia with or without other associated comorbidities. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Dyslipidemias
- 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
- 645 participants
- Where
- 15 sitesin 15 countries
- Study dates
- Dec 2006to Jan 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 > 27 kg/m² and < 40 kg/m²,
- Waist Circumference > 88 cm in women; > 102 cm in men,
- HDL cholesterol < 40 mg/dL (1.03 mmol/L) for men; < 50 mg/dL (1.29 mmol/L) for women, and/or Triglycerides ≥ 150 mg/dL (1.69 mmol/L),
- LDL cholesterol up to 155 mg/dl (4.00 mmol/L) including patients on a stable dose of statins and/or Ezetimibe therapy for at least 8 weeks prior to screening
- Concomitant medications:
- 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
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- 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,
- Triglyceride level > 400 mg/dL (4.52 mmol/L),
- 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,
- Concomitant medications prior to study entry::
- 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
15 sites in 15 countries.
15 sites in 15 countries
About this study
Official title: A 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 Dyslipidemia With or Without Other Comorbidities
Primary :
To determine the effect of Rimonabant 20 mg on changes in, HDL-Cholesterol (HDL-C), triglyceride levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with dyslipidemia with or without other associated comorbidities.
Main Secondary :
To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic and lipid parameters.
To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.
In selected sites, a sub study will be conducted to determine the effect of 12 months of Rimonabant on additional lipoprotein and inflammatory parameters.
- Conditions
- Obesity, Dyslipidemias
- Being tested
- rimonabant, Placebo
- Medical subject headings
- Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rimonabantDrug
Administration of one tablet containing 20 mg of active rimonabantonce daily in the morning.
White film-coated tablets, for oral administration containing 20 mg of active rimonabant
PlaceboDrug
Administration of one rimonabant placebo tablet once daily in the morning. Undistinguishable placebo tablets.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: rimonabant |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HDL-C and triglyceride levels
Measured: From baseline to end of treatment
Secondary outcomes (9)
Waist circumference and body weight
Measured: At each visit
Glycemic parameters : FPG, fasting insulinemia, HbA1c,
Measured: Prior to baseline, month 3, month 6 and month 12.
Lipid parameters : Total Cholesterol, HDL-C, LDL-C, triglyceride levels
Measured: Prior to baseline, month 3, month 6 and month 12.
Inflammatory parameter : Hs-CRP
Measured: Prior to baseline, month 3, month 6 and month 12.
Quality of life : IWQOL questionnaire completed
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: Prior to baseline, month 3, month 6 and month 12.
Standard laboratory assessments
Measured: Prior to baseline and month 12
In selected sites, a sub study will be conducted in which additional Lipid parameters will be measured: HDL subfractions, Apo A1, Apo A2, Apo B and Apo C3, Lp A1, LpA1/A2, Lp(a), Oxidized-LDL and LDL size
Measured: Prior to baseline and at month 12
In selected sites, a sub study will be conducted in which additional Inflammatory parameters will be measured: Adiponectin-High Molecular Weight, Intracellular adhesion molecule 1(ICAM-I) and TNFalpha.
Measured: Prior to baseline and at month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Company decision has been taken in light of recent 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 645 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
- NCT00412698
- Sponsor's protocol ID
- RIMON_R_00962
- Other IDs
- EUDRACT # : 2006-001715-30
- Acronym
- ETERNAL
- Status last verified
- Dec 2010
- First submitted
- 15 Dec 2006
- Last updated
- 10 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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 Dyslipidemia With or Without Other Comorbidities
- ClinicalTrials.gov ID
- NCT00412698
- Acronym / sponsor ID
- ETERNAL / RIMON_R_00962
- Conditions
- Obesity, Dyslipidemias
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision has been taken in light of recent demands by certain national health authorities
- Enrolment
- 645 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 18 Dec 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 :
To determine the effect of Rimonabant 20 mg on changes in, HDL-Cholesterol (HDL-C), triglyceride levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with dyslipidemia with or without other associated comorbidities.
Main Secondary :
To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic and lipid parameters.
To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.
In selected sites, a sub study will be conducted to determine the effect of 12 months of Rimonabant on additional lipoprotein and inflammatory parameters.
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: rimonabant |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BMI > 27 kg/m² and < 40 kg/m²,
- Waist Circumference > 88 cm in women; > 102 cm in men,
- HDL cholesterol < 40 mg/dL (1.03 mmol/L) for men; < 50 mg/dL (1.29 mmol/L) for women, and/or Triglycerides ≥ 150 mg/dL (1.69 mmol/L),
- LDL cholesterol up to 155 mg/dl (4.00 mmol/L) including patients on a stable dose of statins and/or Ezetimibe 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 (34 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 |
|---|---|---|
| rimonabantAdministration of one tablet containing 20 mg of active rimonabantonce daily in the morning. White film-coated tablets, for oral administration containing 20 mg of active rimonabant | Drug | 1 |
| PlaceboAdministration of one rimonabant placebo tablet once daily in the morning. Undistinguishable placebo tablets. | Drug | 2 |
Primary outcome
Change in HDL-C and triglyceride levels
Time frame: From baseline to end of treatment
9 secondary outcomes
Waist circumference and body weight
Time frame: At each visit
Glycemic parameters : FPG, fasting insulinemia, HbA1c,
Time frame: Prior to baseline, month 3, month 6 and month 12.
Lipid parameters : Total Cholesterol, HDL-C, LDL-C, triglyceride levels
Time frame: Prior to baseline, month 3, month 6 and month 12.
Inflammatory parameter : Hs-CRP
Time frame: Prior to baseline, month 3, month 6 and month 12.
Quality of life : IWQOL questionnaire completed
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: Prior to baseline, month 3, month 6 and month 12.
Standard laboratory assessments
Time frame: Prior to baseline and month 12
In selected sites, a sub study will be conducted in which additional Lipid parameters will be measured: HDL subfractions, Apo A1, Apo A2, Apo B and Apo C3, Lp A1, LpA1/A2, Lp(a), Oxidized-LDL and LDL size
Time frame: Prior to baseline and at month 12
In selected sites, a sub study will be conducted in which additional Inflammatory parameters will be measured: Adiponectin-High Molecular Weight, Intracellular adhesion molecule 1(ICAM-I) and TNFalpha.
Time frame: Prior to baseline and at month 12
Results and safety
The study was stopped early (reason given: Company decision has been taken in light of recent 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 10 Dec 2010.
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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.
Valérie Pilorget, MD study director
Sanofi
15 sites in 15 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 and Dyslipidemias, run by Sanofi at 15 sites in 15 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 7 inclusion and 34 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 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Czechia, Finland, Germany, Greece, Hungary and 10 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: Company decision has been taken in light of recent 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?
Change in 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 10 Dec 2010.