E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metabolic syndrome, the essential feature of which is central obesity |
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MedDRA Classification |
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 determine whether treatment of obese subjects with the metabolic syndrome with atorvastatin results in decreased propensity for monocyte chemotaxis. |
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E.2.2 | Secondary objectives of the trial |
To determine the effect of atorvastatin on other aspects of the inflammatory response: serum cytokines, monocyte receptor expression and ability of serum to induce adhesion molecule expression on an endothelial cell line in vitro. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Metabolic syndrome, as defined by the International Diabetes Federation (2005). This is present if a person has central obesity (waist circumference > 94cm for Europid men; > 80 cm for Europid women) plus at least two of the following features:
▪ Blood pressure ≥ 130/85 mmHg, or on treatment for hypertension. ▪ Fasting plasma glucose ≥ 5.6 mmol/l, or previously diagnosed Type II diabetes. ▪ Fasting triglycerides ≥ 1.7 mmol/l. ▪ High-density cholesterol < 1.03 mmol/l (men) or < 1.29 mmol/l (women).
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E.4 | Principal exclusion criteria |
Age < 35 or > 65 Childbearing potential in females Use of lipid-lowering therapy, insulin or hormone replacement therapy History of intolerance of lipid-lowering agents History of muscle disease Plasma total cholesterol >6.5 mmol/l or < 4 mmol/l Liver transaminases greater than twice the upper limit of normal Estimated glomerular filtration rate < 50 mls/min as determined by the abbreviated Modification of Diet in Renal Disease formula Creatine kinase > 140 U/l 10-yr cardiovascular risk >20%, assessed clinically with the help of the Joint British Societies Coronary Risk Prediction Charts
Group 1: 60 subjects, 35-65 years, with the metabolic syndrome as previously defined. Group 2: 40 subjects, 35-65 years, with no features of the metabolic syndrome.
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E.5 End points |
E.5.1 | Primary end point(s) |
Chemotactic response of extracted monocytes Serum inflammatory markers e.g interleukin-8, monocyte chemoattractant protein 1 Monocyte receptor expression Induction of adhesion molecule expression by subject serum on cultured endothelial cells |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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The last, post-treatment, visit of the 60th subject. |
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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 | 2 |
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 | 2 |