E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Overweight patients with additional risk factors. Atherosclerosis progression assessed by carotid artery intima-media thickness (CIMT). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003601 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effect of rimonabant 20-mg once daily in comparison with placebo, on the quantitative progression of atherosclerosis as assessed by CIMT. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of the above rimonabant regimen in the study population of atherosclerotic patients. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Written and signed informed consent • Age ≥ 55 years • Abdominal obesity defined by waist circumference > 88 cm (35 inches) in women or > 102 cm (40 inches) in men • Metabolic syndrome diagnosed on the basis of at least two of the following additional risk factors: - Triglyceride level ≥ 150 mg/dL (1.69 mmol/L) - HDL cholesterol < 40 mg/dL (1.03 mmol/L) [men] or 50 mg/dL (1.28 mmol/L) [women] - Fasting glucose ≥ 110 mg/dL (6.1 mmol/L) - High blood pressure (≥ 140 mmHg systolic and/or ≥ 90 mmHg diastolic) at Screening visit, or current treatment by anti-hypertensive medication • Ultrasonographic evidence at Screening quantitative B-mode ultrasound imaging of a minimal CIMT measurement ≥ 0.7 mm in either of the far walls of the common carotid artery, and maximal CIMT measurement < 3 mm in any carotid artery segment • All 6 carotid artery segment B-mode ultrasound images must allow for CIMT measurements • Screening CIMT recording deemed to be of acceptable CIMT image quality, and demonstrating adherence to the CIMT interrogation protocol, as determined by the Imaging Core Laboratory’s assessment. |
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E.4 | Principal exclusion criteria |
• History of very low-calorie diet or surgical procedures for weight loss (eg, stomach stapling, bypass) within 6 months prior to Screening visit • Obesity of known endocrine origin • Uncontrolled diabetes, ie with HbA1c >10% • Anticipated survival < 27 months • Presence of any severe medical or psychological condition, that in the opinion of the Investigator would compromise the subject’s safety or successful participation in the study • Presence of any other condition (e.g. geographic, social…) actual or anticipated, that the Investigator feels that would restrict or limit the subject’s participation for the duration of the study • Receipt of any investigational treatment (drug or device) within 30 days prior to Screening • Previous participation in a rimonabant study • Total occlusion of any carotid artery segment • Previous history of carotid intervention (carotid surgery, percutaneous carotid intervention…) • Patient considered at high risk of carotid intervention during the next 27 months (eg presence of ulcerative plaque or hemodynamically significant stenosis) • Pathology in near and / or far wall that causes acoustic shadowing of far wall CIMT in any arterial segment • Inability to define the carotid flow divider on either side • Anatomic variables (e.g., obscured vessels due to the mandibular angle, too deep or tortuous vessels) making CIMT measurement impossible in any arterial segment |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the absolute change in averaged per subject CIMT in mm from Baseline to Month 24.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 2 |