E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To evaluate the influence of 12 weeks of ER niacin/laropiprant therapy on endothelial dependent dilatation of the arterial wall in CHD patients already treated with a statin compared to placebo as well as the influence on serum lipids and the parameters of inflammation (TC, LDL, HDL, Tg, NonLDL C, Lp a, CRP, IL-6, TNF-α, TFPI, PAI-1 antigen and activity, t-PA antigen and activity ) in CHD patients already treated with a statin compared to placebo.
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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 evaluate the influence of 12 weeks of ER niacin/laropiprant therapy on endothelial dependent dilatation of the arterial wall in CHD patients already treated with a statin compared to placebo.
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E.2.2 | Secondary objectives of the trial |
Secondary objective: To evaluate the influence of 12 weeks of ER niacin/laropiprant therapy on serum lipids and the parameters of inflammation (TC, LDL, HDL, Tg, NonLDL C, Lp a, CRP, IL-6, TNF-α, TFPI, PAI-1 antigen and activity, t-PA antigen and activity ) in CHD patients already treated with a statin compared to placebo.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- age 35-55, with - confirmed CHD (post MI patients, coronarography and/or cycloergometry) - already treated for dyslipidemia with a statin and reaching ESC LDL target - HDL-C <1.1 mmol/l, TG > 1,7 mmol/l and LDL < 2,6 mmol/L
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E.4 | Principal exclusion criteria |
- 3x increase of liver enzyme tests or CK - severe renal insufficiency – creatinin >200 mmol/l, - acute disease within 6 weeks prior to inclusion, - hypersensitivity to nicotinic acid - other cardiac medication stable for at least 4 weeks prior to enrollment - Acute MI, CABG, PCI within past 3 months. - Congestive heart failure (CHF) _ NYHA 2. - Ejection fraction < 40% measured within the past 6 months. - Malignancy. - HIV infection or immunodeficiency state. - Stable dose of statin < 6 weeks - Diabetes mellitus type 1. - Diabetes mellitus type 2 with HbA1C > 7% - Hypo/hyper thyroidism. - Alcohol or drug abuse
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E.5 End points |
E.5.1 | Primary end point(s) |
I. In patients with CHD ER niacin/laropiprant therapy will cause statistically significant improvement of endothelial dependent dilatation of the arterial wall after 12 weeks of treatment compared to placebo. II. In patients with CHD ER niacin/laropiprant (2 g) daily will be superior to placebo at 12 weeks at increasing HDL-C, decreasing triglycerides, decreasing TC/HDL-C ratio, decreasing LDL-C/HDL-C ratio, decreasing Apo B, increasing Apo A-1
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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 | 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 | 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 | 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 |