E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary prevention of atherosclerotic disease |
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E.1.1.1 | Medical condition in easily understood language |
Primary prevention of atherosclerotic disease |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
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 investigate the effects of genetic variants and other individual factors on statin efficacy, tolerability and concentrations in patients starting a new statin treatment
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Tämän tutkimuksen tavoitteena on tutkia miten geenimuunnokset ja muut yksilölliset tekijät vaikuttavat statiinien tehoon, siedettävyyteen ja pitoisuuksiin potilailla, jotka aloittavat uuden statiinilääkityksen
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E.2.2 | Secondary objectives of the trial |
To investigate the effect of statin therapy on the levels of metabolism-derived products in patients starting a new statin treatment |
Tutkia miten statiinilääkitys vaikuttaa aineenvaihduntatuotteiden pitoisuuksiin potilailla, jotka aloittavat uuden statiinilääkityksen |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• a signed informed consent,
• age ≥18 years,
• an indication for statin treatment in agreement with Finnish standard treatment guidelines ("käypä hoito"),
• a new statin prescription for primary prevention of atherosclerosis |
• allekirjoitettu tietoinen suostumus,
• ikä ≥18 vuotta,
• käypä hoito -suosituksen mukainen indikaatio statiinihoidolle,
• uusi statiinilääkitys ateroskleroottisen sairauden primaaripreventioon |
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E.4 | Principal exclusion criteria |
• a person as defined in sections 7-10§ of the Finnish law on Medical Research (disabled, underage, pregnant, nursing or prisoner),
• a contraindication for statin treatment
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• ”lain lääketieteellisestä tutkimuksesta” 7-10§:ssä tarkoitettu henkilö (vajaakykyinen, alaikäinen, raskaana oleva, imettävä tai vanki),
• vasta-aihe statiinilääkitykselle
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E.5 End points |
E.5.1 | Primary end point(s) |
• % change in LDL cholesterol levels (ΔLDL%),
• statin intolerance
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• LDL-kolesterolipitoisuuden %-muutos (ΔLDL%),
• statiini-intoleranssi
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 and 12 months |
1 ja 12 kk |
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E.5.2 | Secondary end point(s) |
• adherance
• plasma concentrations of statins, their metabolites, and endogenous and nutrition-derived metabolites
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• adherenssi
• statiinien ja niiden aineenvaihduntatuotteiden sekä endogeenisten ja ravintoperäisten aineenvaihduntatuotteiden plasmapitoisuudet
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 and 12 months |
1 ja 12 kk |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Prospektiivinen havainnoiva kliininen tutkimus |
Prospective observational clinical trial |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
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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LVLS, otherwise approximately 12 months after enrollment of 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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |