Rimonabant in Abdominally Obese Patients With Impaired Fasting Blood Glucose (PRADO)
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2666 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Administration of one tablet containing 20 mg of Rimonabant
Once daily in the morning
Placebo Comparator: 2
Administration of one Rimonabant placebo tablet.
Once daily in the morning
- Mean change in the co-primary endpoint : FPG, HDL-C and triglyceride levels. [ Time Frame: From baseline to end of treatment ]
- Waist circumference and body weight [ Time Frame: At each visit ]
- 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. ]
- Quality of life (IWQOL questionnaire completion) [ 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: From the signature of the ICF to the end of the study ]
- Standard laboratory assessments [ Time Frame: Prior to baseline and month 12 ]
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
Show 27 Study Locations
|Study Director:||Valérie Pilorget, MD||Sanofi|