E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020604 |
E.1.2 | Term | Hypercholesterolemia |
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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 demonstrate the efficacy of MK-0524 to protect against niacin-induced flushing in patients who resume therapy with either MK-0524A 2g or ER-niacin 2g after a 5 day drug holiday from a stable dose of MK-0524A 2g. MK 0524A will produce less flushing that ER-niacin as measured by maximum Global Flushing Severity Score (GFSS) categorised into none/mild, moderate, severe, extreme during the first 7 days following a 5-day holiday. |
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E.2.2 | Secondary objectives of the trial |
1)To demonstrate the efficacy of MK-0524 to protect against niacin-induced flushing in patients who resume therapy with either MK-0524A 2g or ER-niacin 2g after a 5 day drug holiday from a stable dose of MK-0524A 2g MK 0524A will produce less flushing that ER-niacin as measured by: a. maximum GFSS during the first 7 days following a 5-day drug holiday b. the percentage of patients with moderate or greaster GFSS(>4) during the first 7 days following a 5-day drug holiday. c. the percentage of patients with moderate or severe GFSS (>7) during the first 7 days following a 5-day drug holiday.
2)To assess the safety and tolerability of MK-0524A.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient is male or female, aged 18 to 70 years. Female patients of reproductive potential agree to be abstinent or to use 2 acceptable methods of birth control for duration of study. Acceptable defined as IUD, diaphragm with spermicide, contraceptive sponge, condom, vasectomy. Patient is appropriate candidate for niacin therapy. Patients with evidence of ischemic cardiovascular disease must be on a statin and have LDL-C <130 mg/dL at V1. Patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have LDL-C <130 mg/dL at V1. Non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have LDL-C <160 mg/dL at V1. Patient has TG <500 mg/dL (5.65 mmol/L) at V1. A patient’s historic serum or plasma lipid values measured within 6 months from Visit 1 may be used to meet lipid inclusion criteria. ALL OTHER PATIENTS DO NOT REQUIRE SPECIFIC LIPID ENTRY CRITERIA. Glycemic status of patient has been determined prior to visit 2. |
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E.4 | Principal exclusion criteria |
Patients with unstable doses of medications. Pregnant or lactating women, or women intending to become pregannt are excluded. Patients with diabetes mellitus that is poorly controlled, newly diagnosed, has recently experienced repeated hypoglycemia or unstable glycemic control, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin). Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, HIV positive, gout (within 1 year).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of maximum GFSS categorized into none/mild, moderate, severe, extreme during the first 7 days following a 5 day drug holiday period will be compared between the MK-0524A/Placebo/MK-0524A treatment group and the MK-0524A/Placebo/ER-Niacin group using the Cochran-Mantel-Haenszel (CMH) test stratified by country. |
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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 | 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) | 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) | Yes |
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
| 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 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 |