Metabolic SyndromePhase 3VICTORIANCT00299325
VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt
A Phase 3 study testing Rimonabant and Mild hypocaloric diet in people with Metabolic Syndrome, run by Sanofi at 9 sites in 9 countries.
Trial summary
Primary objective: To assess the effect of rimonabant on visceral fat area over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with metabolic syndrome Secondary objectives: To assess the effect of rimonabant over a period of 12 months on: Liver fat content using CT… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Rimonabant and Mild hypocaloric diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 9 sitesin 9 countries
- Study dates
- Feb 2006to Jul 2008
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Waist circumference > 102 cm in men and > 88 cm in women
- Two other components of the metabolic syndrome (NCEP/ATPIII definition) among the following :
- Triglyceridemia ≥ 150 mg/dl (or 1.69 mmol/L)
- HDL cholesterol < 50 mg/dL (or 1.29 mmol/L) in women or < 40 mg/dL (or 1.04 mmol/L) in men
- Blood pressure ≥ 130/85 mmHg (systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg) or Treatment with antihypertensive agent(s) for this condition
- Fasting blood glucose > 110 mg/dl (or 6.1 mmol/L)
Who cannot join
- Positive pregnancy test, pregnant or breast-feeding women, or women planning to become pregnant or breastfeed
- Absence of medically approved contraceptive methods for female of childbearing potential
- History of very low-calorie diet (≤ 800 kcal/day) within 3 months prior to screening visit
- History of surgical procedures for weight loss (eg, stomach stapling, bypass).
- Presence of any clinically significant endocrine disease according to the investigator.
- Weight change > 5 kg within 3 months prior to screening visit
Show all 28Show fewer
- Obese patients (BMI> 40 kg/m²)
- Established type 1 or 2 diabetes (treated or untreated): at least 2 measures of fasting blood glucose ≥ 126 mg/dl
- Severe renal dysfunction (creatinine clearance < 30 ml/min) or nephrotic syndrome
- Chronic hepatitis or clinically significant hepatic disease
- Positive test for hepatitis B or C
- Marijuana or hashish users
- Significant haematology abnormalities (haemoglobin < 100 g/L and/or neutrophils < 1.5 G/L and/or platelets < 100 G/L).
- Presence or history of cancer within the past 5 years with the exception of adequately treated basal cell skin cancer or in situ uterine cervical cancer
- Presence or history of severe depression that can be defined as depression which necessitated the patient to be hospitalised, or patient with 2 or more recurrent episodes of depression or an history of suicide attempt
- Presence or history of bulimia or anorexia nervosa (DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria) or binge eating disorders
- Presence of any other condition (eg geographical, social…) current or anticipated that the Investigator feels that would restrict or limit the subject's participation for the duration of the studyRelated to previous or concomitant drugs that could interfere with the evaluation of study drug effects
- Administration of any investigational treatment (drug or device) within 30 days prior to screening
- Previous participation in a rimonabant study
- 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
- thyroid preparations or thyroxin treatment (except in patients on replacement therapy on a stable dose)
- Patient treated within the last 3 months with nicotinic acid, fibrates, bile acid sequestrants or ezetimibe (patients treated with statins can be included if the dose received is stable since at least 3 months and should not be modified during the whole study period).
- Patient treated with antidiabetic drug(s).
- Prolonged use (more than one week) within the last 3 months of systemic corticosteroids, neuroleptics, or antidepressants (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
9 sites in 9 countries.
9 sites in 9 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, 12-Month Study of the Effects of Rimonabant 20mg Once Daily on the Amount and the Activity of Visceral Fat in Abdominally Obese Patients With Metabolic Syndrome.
Primary objective:
To assess the effect of rimonabant on visceral fat area over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with metabolic syndrome
Read more
Secondary objectives:
- To assess the effect of rimonabant over a period of 12 months on:
- Liver fat content using CT scan (Computed Tomography scan)
- Anthropometric measures (weight, waist circumference, body composition using Dual Energy X-ray Absorptiometry (DEXA))
- Lipid, lipoprotein profile
- Glycemia, insulinemia and HbA1c
- Adipokines, inflammatory and hemostatic markers
- To evaluate the percentage of patients with metabolic syndrome at 12 months
- To evaluate the safety and tolerability of rimonabant in these patients
In four selected US sites the effect of rimonabant at 12 months will be also assessed on:
- Basal lipolysis and insulin suppressed lipolysis (euglycemic hyperinsulinemic clamp).
- Resting metabolic rate and substrate oxidation at rest using indirect calorimetry.
- Adipose tissue histology and expression of genes involved in glucose and lipid metabolism (superficial adipose tissue biopsy).
Read the detailed description
The total duration per patient will be approximately 15 months including a 12-month double-blind treatment period.
- Conditions
- Metabolic Syndrome
- Being tested
- Rimonabant, Placebo (for Rimonabant), Mild hypocaloric diet
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimonabantDrug
Also called SR141716, Acomplia
Tablet, oral administration
Placebo (for Rimonabant)Drug
Tablet, oral administration
Mild hypocaloric dietOther
Calculated by the dietitian based on the estimated basal metabolism rate and the physical activity
| Study group | Role | What they receive |
|---|---|---|
| Rimonabant | Experimental | Rimonabant 20 mg once daily with mild hypocaloric diet Receives: Drug: Rimonabant; Other: Mild hypocaloric diet |
| Placebo | Placebo comparator | Placebo (for Rimonabant) once daily with mild hypocaloric diet Receives: Drug: Placebo (for Rimonabant); Other: Mild hypocaloric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in visceral fat area assessed by CT scan
Measured: From baseline to Month 12
Secondary outcomes (7)
Absolute change in visceral fat area assessed by CT scan
Measured: From baseline to Month 12
Change in Liver fat content measured using CT scan
Measured: From baseline to Month 12
Change in anthropometric measures
Measured: From baseline to Month 12
Change in specific lipid parameters
Measured: From baseline to Month 12
Change in glucose control parameters
Measured: From baseline to Month 12
Change in adipokines, inflammatory and hemostatic markers
Measured: From baseline to Month 12
Percentages of patients with a metabolic syndrome
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionJul 2008
- Study completionJul 2008
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 Metabolic SyndromeStudies 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
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valérie Pilorget, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299325
- Sponsor's protocol ID
- PM_C_0172
- Other IDs
- 2005-002568-27, 2005
- Acronym
- VICTORIA
- Status last verified
- Jun 2016
- First submitted
- 3 Mar 2006
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Triay J, Mundi M, Klein S, Toledo FG, Smith SR, Abu-Lebdeh H, Jensen M. Does rimonabant independently affect free fatty acid and glucose metabolism? J Clin Endocrinol Metab. 2012 Mar;97(3):819-27. doi: 10.1210/jc.2011-2486. Epub 2011 Dec 14.
PubMed 22170727
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Two-arm Placebo Controlled, 12-Month Study of the Effects of Rimonabant 20mg Once Daily on the Amount and the Activity of Visceral Fat in Abdominally Obese Patients With Metabolic Syndrome.
- ClinicalTrials.gov ID
- NCT00299325
- Acronym / sponsor ID
- VICTORIA / PM_C_0172
- Conditions
- Metabolic Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Mar 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 assess the effect of rimonabant on visceral fat area over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with metabolic syndrome
Secondary objectives:
- To assess the effect of rimonabant over a period of 12 months on:
- Liver fat content using CT scan (Computed Tomography scan)
- Anthropometric measures (weight, waist circumference, body composition using Dual Energy X-ray Absorptiometry (DEXA))
- Lipid, lipoprotein profile
- Glycemia, insulinemia and HbA1c
- Adipokines, inflammatory and hemostatic markers
- To evaluate the percentage of patients with metabolic syndrome at 12 months
- To evaluate the safety and tolerability of rimonabant in these patients
In four selected US sites the effect of rimonabant at 12 months will be also assessed on:
- Basal lipolysis and insulin suppressed lipolysis (euglycemic hyperinsulinemic clamp).
- Resting metabolic rate and substrate oxidation at rest using indirect calorimetry.
- Adipose tissue histology and expression of genes involved in glucose and lipid metabolism (superficial adipose tissue biopsy).
Detailed description
The total duration per patient will be approximately 15 months including a 12-month double-blind treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rimonabant | Experimental | Drug: Rimonabant, Other: Mild hypocaloric dietRimonabant 20 mg once daily with mild hypocaloric diet |
| Placebo | Placebo comparator | Drug: Placebo (for Rimonabant), Other: Mild hypocaloric dietPlacebo (for Rimonabant) once daily with mild hypocaloric diet |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Waist circumference > 102 cm in men and > 88 cm in women
- Two other components of the metabolic syndrome (NCEP/ATPIII definition) among the following :
Key exclusion criteria (28 listed)
- Positive pregnancy test, pregnant or breast-feeding women, or women planning to become pregnant or breastfeed
- Absence of medically approved contraceptive methods for female of childbearing potential
- History of very low-calorie diet (≤ 800 kcal/day) within 3 months prior to screening visit
- History of surgical procedures for weight loss (eg, stomach stapling, bypass).
- Presence of any clinically significant endocrine disease 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 |
|---|---|---|
| RimonabantAlso: SR141716, AcompliaTablet, oral administration | Drug | Rimonabant |
| Placebo (for Rimonabant)Tablet, oral administration | Drug | Placebo |
| Mild hypocaloric dietCalculated by the dietitian based on the estimated basal metabolism rate and the physical activity | Other | Placebo, Rimonabant |
Primary outcome
Relative change in visceral fat area assessed by CT scan
Time frame: From baseline to Month 12
7 secondary outcomes
Absolute change in visceral fat area assessed by CT scan
Time frame: From baseline to Month 12
Change in Liver fat content measured using CT scan
Time frame: From baseline to Month 12
Change in anthropometric measures
Time frame: From baseline to Month 12
Change in specific lipid parameters
Time frame: From baseline to Month 12
Change in glucose control parameters
Time frame: From baseline to Month 12
Change in adipokines, inflammatory and hemostatic markers
Time frame: From baseline to Month 12
Percentages of patients with a metabolic syndrome
Time frame: At 12 months
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 6 Jun 2016.
- Results publication: PubMed 22170727Triay J, Mundi M, Klein S, Toledo FG, Smith SR, Abu-Lebdeh H, Jensen M. Does rimonabant independently affect free fatty acid and glucose metabolism? J Clin Endocrinol Metab. 2012 Mar;97(3):819-27. doi: 10.1210/jc.2011-2486. Epub 2011 Dec 14.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimonabant and Mild hypocaloric diet in people with Metabolic Syndrome, run by Sanofi at 9 sites in 9 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 28 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 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada, Denmark, Finland, France and 4 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 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?
Relative change in visceral fat area assessed by CT scan (time frame: From baseline to Month 12). 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 NCT00299325, 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 6 Jun 2016.