NCT00412698|TerminatedPhase 3

Study Stopped

Company decision has been taken in light of recent demands by certain national health authorities

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

ETERNAL

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

Sanofi ClinicalTrials.gov

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2 other identifiers

RIMON_R_00962EUDRACT # : 2006-001715-30

Study Type

interventional

Target

645

Locations

15 countries

Sites

Timeline

RegisteredDec 2006

StartedDec 2006

CompletionJan 2009

Brief Summary

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.

Trial Health

Monitor

Trial Health Score

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

Enrollment

645

participants targeted

Target at P75+ for phase_3 obesity

Timeline

Completed

Started Dec 2006

Geographic Reach

15 countries

15 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

2.1 years study duration

Study Start

First participant enrolled

December 1, 2006

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2006

Completed

3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2006

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed

Last Updated

December 10, 2010

Status Verified

December 1, 2010

Enrollment Period

2.1 years

First QC Date

December 15, 2006

Last Update Submit

December 9, 2010

Conditions

Obesity Dyslipidemias

Outcome Measures

Primary Outcomes (1)

Change in HDL-C and triglyceride levels
From baseline to end of treatment

Secondary Outcomes (9)

Waist circumference and body weight
At each visit
Glycemic parameters : FPG, fasting insulinemia, HbA1c,
Prior to baseline, month 3, month 6 and month 12.
Lipid parameters : Total Cholesterol, HDL-C, LDL-C, triglyceride levels
Prior to baseline, month 3, month 6 and month 12.
Inflammatory parameter : Hs-CRP
Prior to baseline, month 3, month 6 and month 12.
Quality of life : IWQOL questionnaire completed
At baseline, month 3, month 6, month 9 and month 12.
+4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Drug: rimonabant

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

rimonabantDRUG

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

PlaceboDRUG

Administration of one rimonabant placebo tablet once daily in the morning. Undistinguishable placebo tablets.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

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.

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,
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),
+19 more criteria

Contact the study team to confirm eligibility.