NCT00405808|TerminatedPhase 3

Study Stopped

EMEA recommendation to suspend Acomplia marketing authorisation

Rimonabant in Abdominally Obese Patients With Impaired Fasting Blood Glucose

PRADO

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

Sanofi ClinicalTrials.gov

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2 other identifiers

RIMON_R_00961EUDRACT # : 2006-001711-30

Study Type

interventional

Target

2,666

Locations

27 countries

Sites

Timeline

RegisteredNov 2006

StartedDec 2006

CompletionFeb 2009

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,666

participants targeted

Target at P75+ for phase_3 obesity

Timeline

Completed

Started Dec 2006

Geographic Reach

27 countries

27 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

First Submitted

Initial submission to the registry

November 28, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed

1 day until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed

Last Updated

January 26, 2011

Status Verified

January 1, 2011

Enrollment Period

2.2 years

First QC Date

November 28, 2006

Last Update Submit

January 25, 2011

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

Mean change in the co-primary endpoint : FPG, HDL-C and triglyceride levels.
From baseline to end of treatment

Secondary Outcomes (5)

Waist circumference and body weight
At each visit
Glycemic parameters (FPG, fasting insulinemia, HbA1c), lipid parameters (Total Cholesterol, HDL-C, LDL-C, triglyceride levels), inflammatory parameter (Hs-CRP),
All these laboratory parameters will be measured prior to baseline, month 3, month 6 and month 12.
Quality of life (IWQOL questionnaire completion)
At baseline, month 3, month 6, month 9 and month 12
Incidence of adverse events in each group, including neuro-psychiatric adverse events
From the signature of the ICF to the end of the study
Standard laboratory assessments
Prior to baseline and month 12

Study Arms (2)

1

EXPERIMENTAL

Administration of one tablet containing 20 mg of Rimonabant

Drug: Rimonabant

2

PLACEBO COMPARATOR

Administration of one Rimonabant placebo tablet.

Drug: Placebo

Interventions

RimonabantDRUG

Once daily in the morning

PlaceboDRUG

Once daily in the morning

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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),
+18 more criteria

Contact the study team to confirm eligibility.