A RANDOMIZED, DOUBLE BLIND, TWO ARM, PARALLEL, PLACEBO CONTROLLED STUDY OF RIMONABANT 20MG EFFECT ON HIGH DENSITY LIPOPROTEIN KINETICS IN PATIENTS WITH ABDOMINAL OBESITY AND ADDITIONAL CARDIOMETABOLIC RISK FACTORS - HDL TURNOVER

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2006-001716-71-FR
• Date of registration: 29/12/2006
• Prospective Registration: Yes
• Primary sponsor: sanofi aventis Groupe
• Public title: A RANDOMIZED, DOUBLE BLIND, TWO ARM, PARALLEL, PLACEBO CONTROLLED STUDY OF RIMONABANT 20MG EFFECT ON HIGH DENSITY LIPOPROTEIN KINETICS IN PATIENTS WITH ABDOMINAL OBESITY AND ADDITIONAL CARDIOMETABOLIC RISK FACTORS - HDL TURNOVER
• Scientific title: A RANDOMIZED, DOUBLE BLIND, TWO ARM, PARALLEL, PLACEBO CONTROLLED STUDY OF RIMONABANT 20MG EFFECT ON HIGH DENSITY LIPOPROTEIN KINETICS IN PATIENTS WITH ABDOMINAL OBESITY AND ADDITIONAL CARDIOMETABOLIC RISK FACTORS - HDL TURNOVER
• Date of first enrolment: 17/09/2007
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001716-71
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): Therapeutic exploratory (Phase II): Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV):

Countries of recruitment

Finland, France, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1) Informed consent must be obtained in writing for all patients at enrollment into the study
2) Male or female 35-65 years of age
3) Females must be post-menopausal (menopause is defined as 6 months of amenorrhea and plasma FSH > 20 U/L)
4) BMI > 27 kg/m² and < 40 kg/m²
5) Willingness and ability to comply with the study protocol
6) Men or women with abdominal obesity according to NCEP/ATPIII criteria: Waist Circumference > 88 cm in women; > 102 cm in men.
7) With at least one lipid abnormality defined as:
- Fasting Triglycerides level >1.7 mmol/L (150 mg/dL) and < 4.5 mmol/L (400 mg/dL)
- HDL < 1.03 mmol/L (40 mg/dL) in men and < 1.29 mmol/L (50 mg/dL) in women


Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1) HDL< or = 0.60 mmol/L (23 mg/dl)
2) Plasma LDL-Cholesterol > 155 mg/dl (4.00 mmol/L) or total cholesterol 250 mg/dl (> 6.5mmol/L) or genetic hyperlipidaemia
3) Fasting triglycerides > 400 mg/dL (4.5 mmol/L)
4) Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
5) ApoE2/E2 homozygosity, Apo E4/E4 homozygosity
6) Type 2 diabetes treated with oral agents and/or insulin
7) Diet treated type 2 diabetic patients with HbA1c = 7%
8) History of cardio vascular disease (myocardial infarction, angina, stroke, confirmed peripheral arterial disease, coronary and peripheral vascular Surgery (CABG, PCI…)
9) Systolic blood pressure = 160 mm Hg or diastolic blood pressure = 95 mm Hg
10) Very low-calorie diet (1200 calories a day or less) or history of surgical procedures for weight loss (e.g., stomach stapling, bypass)
11) Body weight fluctuation > 5 Kg during the previous 3 months
12) History of bulimia or anorexia nervosa by DSM-IV criteria
13) Presence of any clinically significant endocrine disease according to the investigator, Cushing syndrome, obesity secondary to hypothalamic/pituitary disorder
14) Abnormal TSH and free T4 at baseline (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)
15) Severe hepatic impairment known by the investigator or AST or ALT > 3 times the ULN at screening. In this case, a second determination of hepatic tests will be performed after one week. If the dysfunction is confirmed, the patient must not be included in the study
16) Known severe renal dysfunction (creatinine clearance < 30 ml/min) or urine analysis (performed at screening by dipstick) showing 2+ or more protein
17) Presence of any condition (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actual or anticipated that the investigator feels would compromise the patient safety or limit his/her successful participation to the study:
• Any current malignancy or any cancer within the past five years (except adequately treated basal cell skin cancer or cervical carcinoma in situ)
• Any history of cardiac failure
• Relevant acute abnormal finding seen on ECG
• Significant haematology abnormalities (haemoglobin < 120 g/L and/or neutrophils < 1.5 G/L and/or platelets < 100 G/L)

18) Patient treated for epilepsy
19) Uncontrolled serious psychiatric illness such as a major depression
20) History of alcohol and/or drug abuse
21) Smoker or smoking cessation within the past 3 months
22) Marijuana or hashish users
23) Previous participation in a Rimonabant study or to any other clinical trial within 4 weeks to study start
24) Hypersensitivity/intolerance to the active substance or to any of the excipients such as lactose
25) Blood donation within the past 3 months prior to the study or planned during the study or within the 3 months from the study completing
26) History of peptic ulcer
27) Willebrand disease or other hemorrhagic diatheses

Concomitant medications prior and during the study:
28) Administration of any of the following within 3 months prior to screening visit and susceptible to be prescribed during the study treatment period:
- Lipid-lowering drugs intake (statin, fibrate, bile acid sequestrant, ezetimibe, nicotinic acid)
- Other drugs for weight reduction (phentermine, amphetamines)
- Other

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

PATIENTS WITH ABDOMINAL OBESITY AND ADDITIONAL CARDIOMETABOLIC RISK FACTORS
MedDRA version: 8.1 Level: LLT Classification code 10059179 Term: Abdominal obesity

Intervention(s)

Trade Name: Acomplia
Product Name: rimonabant
Product Code: SR141716
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: rimonabant
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: - To assess effect of Rimonabant on HDL ApoA-I production rate (PR) and on other lipoprotein kinetics.
- To assess effect of Rimonabant on lipids, glycemic and inflammatory parameters
- To assess effect of Rimonabant on body composition
- To assess safety of Rimonabant

Primary end point(s): The primary end point is the fractional catabolic rate (FCR) of ApoA-1 in HDL after 12 months of treatment.

Main Objective: The Primary End-point is the fractional catabolic rate of ApoA-I in HDL after 12 months of treatment.

Secondary ID(s)

RIMON_C_01346

2006-001716-71-FI

Ethics review

Status: Approved
Approval date: 10/01/2006
Contact:

Results

• Results available: Yes
• Date Posted: 17/11/2016
• Date Completed: 18/12/2008
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-001716-71/results