E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Objectives:To investigate whether statins (3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors) improve endothelial dysfunction in healthy volunteers (men). Endothelial dysfunction is an early marker of atherosclerosis.
Design: Phase IV, Single-centered, Open label, 20 male volunteers, Proof of concept study
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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 |
Does simvastatin improve endothelial dysfunction in men? |
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E.2.2 | Secondary objectives of the trial |
Does simvastatin improve nitric oxide (NO) bioavailability in conduit and resistance vessels of healthy young men? Does simvastatin increase endothelial progenitor cell number and function in healthy young men?
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
We will recruit sedentary * Males * Age 18 to 40 years * Body mass index <30 kg/m2 * Normotensive * Non-diabetic * Non-smokers * Normal liver function, haematology and cholesterol.
Healthy subjects will be identified by taking a medical history at the preliminary visit by a medically qualified researcher.
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E.4 | Principal exclusion criteria |
* Female gender * Age <18 or >40 years * Hypertension * Diabetes mellitus * Current smokers * Liver disease (including abnormal liver function tests and / or a history of liver disease) * Alcohol abuse * Cancer * Ischaemic heart disease * Unwilling to refrain from drinking grapefruit juice * Currently taking statins * Contraindications to statins (according to the British National Formulary and assessed by taking a history and blood tests at the preliminary visit). * Ingestion of large quantities of grapefruit juice * Participating in another trial or have done so in the last 30 days
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E.5 End points |
E.5.1 | Primary end point(s) |
Measures of endothelial dysfunction in men
Secondary endpoints:Nitric oxide (NO) bioavailability in conduit and resistance vessels and endothelial progenitor cell number and function
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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 | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Proff of concept study to ascertain whether Simvastatin modifies endothelial function in healthy men |
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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) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Yes |
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 end of the trial will be 30 days after the last visit of the last 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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |