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 | 6.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10020666 |
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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 |
Primary: In patients with primary hypercholesterolemia or mixed hyperlipidemia, (1) evaluate the efficacy of MK-0524A 2g relative to placebo on plasma concentrations of low-density lipoprotein cholesterol (LDL-C), and (2) assess the effects of MK 0524A relative to ER-niacin on flushing during the acute dosing period |
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E.2.2 | Secondary objectives of the trial |
evaluate the efficacy of MK-0524A 2g relative to placebo on plasma concentrations of HDL-C, triglycerides (TG), LDL-C:HDL-C ratio, non-HDL-C, Apo B, and Apo A-I, (2) assess the effects of MK-0524A relative to ER-niacin on flushing |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
e. Patient meets one of the following criteria (based on NCEP ATP III categorization of CHD risk:
Patient is on a statin and is high risk (CHD/CHD risk equivalent including diabetes) according to NCEP ATP III criteria with an LDL-C <100 mg/dL (2.59 mmol/L).
Patient is on a statin and has multiple risk factors (≥2 RF) according to NCEP ATP III criteria with an LDL-C <130 mg/dL (3.37 mmol/L).
Patient is on a statin and is low risk [0-1 RF; target LDL-C <160 mg/dL (4.14 mmol/L)] according to NCEP ATP III criteria with an LDL-C ≥130 mg/dL and ≤190 mg/dL (3.37 and 4.92 mmol/L).
Patient is not on a statin or other lipid-modifying therapy and is low risk [0-1 RF; target LDL-C <160 mg/dL (4.14 mmol/L)] according to NCEP ATP III criteria with an LDL-C ≥130 mg/dL and ≤190 mg/dL (3.37 and 4.92 mmol/L).
f. Patient has TG ≤350 mg/dL (3.95 mmol/L). |
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E.4 | Principal exclusion criteria |
a. Patient is pregnant or breast-feeding, or expecting to conceive during the study including the 14-day post study follow-up.
d. Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patients participation for the full duration of the study, or is not in the best interest of the patient to participate.g. Patient is currently participating in or has participated in a study with: |
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E.5 End points |
E.5.1 | Primary end point(s) |
efficacy of MK-0524A 2g relative to placebo on plasma concentrations of low-density lipoprotein cholesterol (LDL-C). |
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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 | 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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | 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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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 | 10 |
E.8.9.1 | In the Member State concerned days | |
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 | 10 |