DyslipidemiaPhase 3ADAGIO-lipidsNCT00239967
An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients
A Phase 3 study testing Rimonabant (SR141716) in people with Dyslipidemia and Obesity, run by Sanofi at 14 sites in 14 countries.
Trial summary
The purpose of this study is to assess the effect of rimonabant 20 mg on HDL (high density lipoprotein) cholesterol and on TG (triglycerides) plasma levels over a period of one year when prescribed with a hypocaloric diet (600 kcal deficit per day) in abdominally obese patients with atherogenic dyslipidemia (low HDL… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia, Obesity
- What is being tested?
- Rimonabant (SR141716)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 803 participants
- Where
- 14 sitesin 14 countries
- Study dates
- May 2005to Feb 2007
- 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
- Male or female patients aged >= 18 years
- Waist circumference > 102 cm in men and > 88 cm in women
- Dyslipidemia consisting of:
- Triglyceridemia >= 1.5g/L (i.e. 1.69mmol/L) and ≤ 7.0g/L (i.e. 7.90mmol/L) AND/OR
- HDL cholesterol < 50mg/dL (1.29mmol/L) in women, < 40mg/dL (1.04mmol/L) in men
- If patient with type 2 diabetes are included they must be on a stable dose of oral antidiabetic medication (excluding glitazones) and should not be on insulin therapy
- Written informed consent
Who cannot join
- Weight change > 5 kg within 3 months prior to screening visit
- Pregnancy or lactation, or women planning to become pregnant
- Absence of medically approved contraceptive methods for females of childbearing potential
- Presence of any other condition (e.g. geographic, social…) actual or anticipated, that the Investigator feels that would restrict or limit the subject's participation for the duration of the study.
- Presence of any clinically significant endocrine disease (other than type 2 diabetes) according to the Investigator
- History of severe depression that could be defined as depression which necessitated the patient to be hospitalized, or patients with 2 or more recurrent episodes of depression or a history of suicide attempt.
Show all 15Show fewer
- Presence or history of DSM-IV bulimia or anorexia nervosa- Positive test for hepatitis B surface antigen and/or hepatitis C antibody; Abnormal TSH level (TSH > ULN or < LLN ); Hemoglobin < 11g/dL and/or neutrophils > 1,500/mm3 and/or platelets < 100,000/mm3; Positive urine pregnancy test in females of childbearing potential.
- Within 3 months prior to screening visit and between the screening and the inclusion visit:
- Administration of anti obesity drugs (e.g., sibutramine, orlistat)
- Administration of other drugs for weight reduction including herbal preparations (phentermine, amphetamines)
- Thyroid preparations or thyroxine treatment (except in patients on replacement therapy on a stable dose)
- If patients with type 2 diabetes are included they must be on a stable dose of oral antidiabetic medication for at least 3 months and should not be expected to receive insulin therapy within 12 months: Insulin, Glitazones
- Any change in lipid lowering treatment (i.e. introduction of a new drug, change, cessation)- Administration of systemic long-acting corticosteroids- Prolonged use (more than 1 week) of systemic corticosteroids (or if daily dosage > 1000 µg equivalent beclomethasone
- Prolonged administration (more than one week) of antidepressants (including bupropion)
- Prolonged administration (more than one week) of neuroleptics.
Trial locations and contacts
14 sites in 14 countries.
14 sites in 14 countries
United States1 site
Sanofi-aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Randomized, Double-Blind, Two-Arm Placebo-Controlled, Parallel-Group, Multicenter Study of Rimonabant 20 mg Once Daily in the Treatment of Atherogenic Dyslipidemia in Abdominally Obese Patients
The purpose of this study is to assess the effect of rimonabant 20 mg on HDL (high density lipoprotein) cholesterol and on TG (triglycerides) plasma levels over a period of one year when prescribed with a hypocaloric diet (600 kcal deficit per day) in abdominally obese patients with atherogenic dyslipidemia (low HDL and/or high TG plasma levels). The secondary objectives are to evaluate specific metabolic parameters, visceral fat (in selected sites), safety and tolerability of rimonabant 20 mg.
- Conditions
- Dyslipidemia, Obesity
- Being tested
- Rimonabant (SR141716), Placebo
- Keywords
- dyslipidemia, obesity
- Medical subject headings
- Dyslipidemias, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimonabant (SR141716)Drug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL cholesterol and TG plasma levels over a period of one year.
Secondary outcomes (1)
Cholesterol content of HDL2 and HDL3 subfractions,HDL particle size,ApoB,ApoA1,ApoCIII, FFA, indeces of LDL size,hs-CRP,adipokines, fasting glycemia and insulinemia, HbA1c),waist and weight measurements,visceral fat measured by CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startMay 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- 803 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
- NCT00239967
- Sponsor's protocol ID
- EFC5823
- Acronym
- ADAGIO-lipids
- Status last verified
- Apr 2009
- First submitted
- 13 Oct 2005
- Last updated
- 7 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Two-Arm Placebo-Controlled, Parallel-Group, Multicenter Study of Rimonabant 20 mg Once Daily in the Treatment of Atherogenic Dyslipidemia in Abdominally Obese Patients
- ClinicalTrials.gov ID
- NCT00239967
- Acronym / sponsor ID
- ADAGIO-lipids / EFC5823
- Conditions
- Dyslipidemia, Obesity
- Keywords
- dyslipidemia, obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 17 Oct 2005 (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 purpose of this study is to assess the effect of rimonabant 20 mg on HDL (high density lipoprotein) cholesterol and on TG (triglycerides) plasma levels over a period of one year when prescribed with a hypocaloric diet (600 kcal deficit per day) in abdominally obese patients with atherogenic dyslipidemia (low HDL and/or high TG plasma levels). The secondary objectives are to evaluate specific metabolic parameters, visceral fat (in selected sites), safety and tolerability of rimonabant 20 mg.
Study design
- Primary purpose
- Treatment
- 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
Key inclusion criteria (7 listed)
- Male or female patients aged >= 18 years
- Waist circumference > 102 cm in men and > 88 cm in women
- Dyslipidemia consisting of:
- Triglyceridemia >= 1.5g/L (i.e. 1.69mmol/L) and ≤ 7.0g/L (i.e. 7.90mmol/L) AND/OR
- HDL cholesterol < 50mg/dL (1.29mmol/L) in women, < 40mg/dL (1.04mmol/L) in men
Key exclusion criteria (15 listed)
- Weight change > 5 kg within 3 months prior to screening visit
- Pregnancy or lactation, or women planning to become pregnant
- Absence of medically approved contraceptive methods for females of childbearing potential
- Presence of any other condition (e.g. geographic, social…) actual or anticipated, that the Investigator feels that would restrict or limit the subject's participation for the duration of the study.
- Presence of any clinically significant endocrine disease (other than type 2 diabetes) according to the Investigator
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 | – |
| Placebo | Drug | – |
Primary outcome
HDL cholesterol and TG plasma levels over a period of one year.
1 secondary outcome
Cholesterol content of HDL2 and HDL3 subfractions,HDL particle size,ApoB,ApoA1,ApoCIII, FFA, indeces of LDL size,hs-CRP,adipokines, fasting glycemia and insulinemia, HbA1c),waist and weight measurements,visceral fat measured by CT scan
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 7 Apr 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 CSD study director
Sanofi
14 sites in 14 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 Dyslipidemia and Obesity, run by Sanofi at 14 sites in 14 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 15 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: finished, as of the sponsor's last update on 7 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 14 sites in United States, Australia, Brazil, Canada, Denmark and 9 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. 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?
HDL cholesterol and TG plasma levels over a period of one year.. 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 7 Apr 2009; AzTrials last refreshed its copy on 8 Nov 2026.