E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
coronary artery disease and lipid disorder |
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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 |
Hypothesis to be tested: Extended-release niacin increases myocardial blood flow reserve in patients with coronary artery disease (CAD) treated with statins |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Age >35years. 2.Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device. 3.CAD, angiographically documented 4.HDL-C <45mg% 5.LDL-C <150mg% 6.Current treatment with statin (allowed are: Lovastatin, daily dose ≤40mg; Simvastatin, daily dose ≤40mg; Pravastatin, daily dose ≤40mg; Fluvastatin, daily dose ≤40mg; Atorvastatin, daily dose ≤40mg) 7.Informed consent
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E.4 | Principal exclusion criteria |
1.Intolerance to niacin 2.Significant liver disease or liver dysfunction (present or history) 3.Active peptic ulcer disease within 3 months 4.Arterial bleeding 5.Known Ethanol abuse 6.Abnormal liver enzymes (>3x upper normal reference value) 7.Hereditary muscle disease 8.History of myopathy or myositis under HMG-CoA-Reductase-Inhibitor or fibrate 9.Abnormal serum creatine-kinase (>3x upper normal reference value) 10.Concomitant use of medication with a high probability of increasing the risk for hepatotoxicity or myopathy, such as those predominantly metabolized by cytochrome P450 system 3A4, including fibrates, cyclosporine, amiodarone, verapamil, diltiazem, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycine, human immunodeficiency virus protease inhibitors, nefazodone, danazol; lipid-lowering drugs such as bile-acid sequestrants, cholesterol absorption inhibitors (e.g., ezetimibe); high-dose, antioxidant vitamins (vitamins C, E, or beta carotene) that can interfere with the HDL-raising effect of niacin. 11.Renal insufficiency with serum creatinine >2,0mg% 12.Untreated hypothyroidism 13.Uncontrolled diabetes mellitus with fasting glucose >180mg% or hemoglobin A1c >9%. 14.Thrombocytopenia < 100Giga/l 15.Arterial hypotension (systolic blood pressure <90mmHg) 16.Myocardial infarction, PTCA or CABG within 3months 17.Need for coronary revascularization within next 6 months 18.Chronic obstructive pulmonary disease requiring medication 19.High-grade AV-block 20.Pregnant or nursing women 21.Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk form his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study 22.Participation in other clinical trial 30days before randomization
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E.5 End points |
E.5.1 | Primary end point(s) |
Myocardial blood flow and flow reserve assessed by 13N-Ammonia-PET (rest/dipyridamol) before and after 6 month therapy |
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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 | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
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.8.3 |
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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Patients may be withdrawn from the study prematurely for one of the following reasons: 1.Adverse event 2.Abnormal laboratory value 3.Abnormal test procedure 4.Protocol violation 5.Subject withdrew consent 6.Lost to follow-up 7.Administrative problems 8.Death
The study may be terminated by the investigator-sponsor in case of: •Risk-benefit evaluation changes due to unexpected SAEs •Safety concerns •Recruitment of planned patient number is not feasible within reasonable time limits |
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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 | |
E.8.9.1 | In the Member State concerned days | |