European Trial About Effect of RimoNabant on Abdominal Obese Patients With dysLipidemia (ETERNAL)

This study has been terminated.
(Company decision has been taken in light of recent demands by certain national health authorities)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00412698
First received: December 15, 2006
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Obesity
Dyslipidemias
Drug: rimonabant
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in HDL-C and triglyceride levels [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Waist circumference and body weight [ Time Frame: At each visit ] [ Designated as safety issue: No ]
  • Glycemic parameters : FPG, fasting insulinemia, HbA1c, [ Time Frame: Prior to baseline, month 3, month 6 and month 12. ] [ Designated as safety issue: No ]
  • Lipid parameters : Total Cholesterol, HDL-C, LDL-C, triglyceride levels [ Time Frame: Prior to baseline, month 3, month 6 and month 12. ] [ Designated as safety issue: No ]
  • Inflammatory parameter : Hs-CRP [ Time Frame: Prior to baseline, month 3, month 6 and month 12. ] [ Designated as safety issue: No ]
  • Quality of life : IWQOL questionnaire completed [ Time Frame: At baseline, month 3, month 6, month 9 and month 12. ] [ Designated as safety issue: No ]
  • Incidence of adverse events in each group, including neuro-psychiatric adverse events [ Time Frame: Prior to baseline, month 3, month 6 and month 12. ] [ Designated as safety issue: Yes ]
  • Standard laboratory assessments [ Time Frame: Prior to baseline and month 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 645
Study Start Date: December 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rimonabant

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

Placebo Comparator: 2 Drug: Placebo
Administration of one rimonabant placebo tablet once daily in the morning. Undistinguishable placebo tablets.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412698

Locations
Czech Republic
Sanofi-Aventis Administrative Office
Prague, Czech Republic
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Greece
Sanofi-Aventis Administrative Office
Athens, Greece
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Ireland
Sanofi-Aventis Administrative Office
Dublin, Ireland
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Norway
Sanofi-Aventis Administrative Office
Lysaker, Norway
Portugal
Sanofi-Aventis Administrative Office
Porto-Salvo, Portugal
Slovakia
Sanofi-Aventis Administrative Office
Bratislava, Slovakia
Sweden
Sanofi-Aventis Administrative Office
Stockholm, Sweden
Switzerland
Sanofi-Aventis Administrative Office
Meyrin, Switzerland
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Valérie Pilorget, MD Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00412698     History of Changes
Other Study ID Numbers: RIMON_R_00962, EUDRACT # : 2006-001715-30
Study First Received: December 15, 2006
Last Updated: December 9, 2010
Health Authority: Portugal: National Pharmacy and Medicines Institute

Additional relevant MeSH terms:
Obesity
Dyslipidemias
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014