E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
endothelial dysfunction in cardiovascular diseases |
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E.1.1.1 | Medical condition in easily understood language |
endothelial dysfunction in cardiovascular diseases |
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E.1.1.2 | Therapeutic area | Body processes [G] - Ocular Physiological Phenomena [G14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10048554 |
E.1.2 | Term | Endothelial dysfunction |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
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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 investigate the changes of flicker induced vasodilatation and retinal oxygen saturation before and during therapy with simvastatin as well as after simvastatin withdrawal. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Informed consent for participation - Men and women aged between 18 and 45 years, non-smokers - Body mass index between 15th and 85th percentile - Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant - Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant - Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg - Normal ophthalmic findings, ametropia less than 6 diopters |
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E.4 | Principal exclusion criteria |
- History or presence of ocular disease - Ametropy ≥ 6 dpt - Previous or current treatment with statins - Treatment with any drug in the 3 weeks preceding the first study day - Symptoms of a clinically relevant illness in the 3 weeks before the first study day - Participation in a clinical trial in the 3 weeks preceding the first study day - Blood donation during the 3 weeks preceding the first study day - History of family history of epilepsy - History or presence of myopathy, renal failure or elevation of creatine kinase (CK) - above normal levels - History or presence of hepatic dysfuncion, including increase of liver enzymes - Abuse of alcoholic beverages - Pregnancy |
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in flicker induced vasodilatation after discontinuation of simvastatin |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
3, 7 and 14 days after discontinuation of simvastatin |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
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 | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |