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Trial record 30 of 78 for:    sanofi-aventis and sweden

Rimonabant in Abdominally Obese Patients With Impaired Fasting Blood Glucose (PRADO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00405808
Recruitment Status : Terminated (EMEA recommendation to suspend Acomplia marketing authorisation)
First Posted : November 30, 2006
Last Update Posted : January 26, 2011
Sponsor:
Information provided by:
Sanofi

Brief 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 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.


Condition or disease Intervention/treatment Phase
Obesity Drug: Rimonabant Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2666 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: 1
Administration of one tablet containing 20 mg of Rimonabant
Drug: Rimonabant
Once daily in the morning

Placebo Comparator: 2
Administration of one Rimonabant placebo tablet.
Drug: Placebo
Once daily in the morning




Primary Outcome Measures :
  1. Mean change in the co-primary endpoint : FPG, HDL-C and triglyceride levels. [ Time Frame: From baseline to end of treatment ]

Secondary Outcome Measures :
  1. Waist circumference and body weight [ Time Frame: At each visit ]
  2. 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. ]
  3. Quality of life (IWQOL questionnaire completion) [ Time Frame: At baseline, month 3, month 6, month 9 and month 12 ]
  4. 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 ]
  5. Standard laboratory assessments [ Time Frame: Prior to baseline and month 12 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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 /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:

    1. Anti obesity drugs (eg, sibutramine, orlistat),
    2. Other drugs for weight reduction (phentermine, amphetamines),
    3. Herbal preparations for weight reduction,
    4. Nicotinic acid, fibrates or bile acid sequestrants ,
    5. Prolonged use (more than one week) of systemic corticosteroids, neuroleptics.
    6. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405808


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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Valérie Pilorget, MD Sanofi

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Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00405808     History of Changes
Other Study ID Numbers: RIMON_R_00961
EUDRACT # : 2006-001711-30
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: January 26, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
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Rimonabant
Anti-Obesity Agents
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs