E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The proposed study investigates post-prandial hypertriglyceridemia, i.e. patients with a pathological increase in serum-triglyceride levels after intake of a fatty meal. |
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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 show if omega-3 fatty acids (Zodin(R)) can improve post-prandial triglyceride tolerance, defined as the increase in serum triglycerides 2h, 3h, and 5, after intake of a fatty meal. |
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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 |
- stable coronary artery disease - pathological triglyceride tolerance (defined as highest quintile in a a study we are currently performing on 500 patients to define triglyceride tolerance) - age > 18 - written informed consent - established medical therapy for coronary artery disease according to current guidelines, including statin, aspirin, and renin-angiotensin-inhibitor (ACE-I or ARB)
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E.4 | Principal exclusion criteria |
- intolerance to soy or peanuts - anticoagulant therapy - acute coronary syndrome - hemodynamically relevant heart rhythm abnormalities - high grade valve pathologies - severe disease affecting well-being of patients, such as gastroinstestinal disease, acute infection, exsiccosis, pain, decompensated heart failure, recent (< 4 weeks) operation -severe liver or kidney malfunction (ALAT/ALAT > 2.5-fold upper limit of normal, glomerular filtration rate < 30 ml/min) - intolerance to lipid test: acute and chronic pancreatitis, symptomatic cholecystitis, instestinal malabsoprtion - intolerance to milk (products) - problems swallowing and danger of aspiration - pregnancy and lactation - oncological disease - inability to provide written informed consent - psychiatric disorders including substance abuse
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end point is the post-prandial triglyceride kinetic, determined by an oral triglyceride tolerance test (oTT), after three weeks of treatment. After blood is taken for a lipid profile (including serum triglycerides, cholesterol, LDL- and HDL-cholesterol), patients will consume 250 ml of cream. Serum-triglyceride rise will be monitored at 2, 3 and 5 hours. We expect the study medication (Zodin) to improve triglyceride tolerance. |
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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 | 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 | 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 | Yes |
E.8.1.6 | Cross over | Yes |
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 | 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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The trial will be ended once the study phase (3 weeks treatment, 3 weeks washout phase, 3 weeks treatment) is finished. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |