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 | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020603 |
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E.1.3 | Condition being studied is a rare disease | Information not present in EudraCT |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Main objective : In patients taking a statin and admitted to a hospital for investigation of a coronary event, to evaluate the efficacy of switching to ezetimibe/simvastatin (10mg/40mg) on discharge compared to doubling the statin dose as added by the LDL-C values achieved after 12 weeks of treatment. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives : 1) to determine the effect of ezetimibe/simvastatin (10mg/40mg) compared to doubling the statin dose on total cholesterol 2) to determine the effect of ezetimibe/simvastatin (10mg/40mg) compared to doubling the statin dose on triglycerides, high-density lipoprotein cholesterol (HDL-C), and non-HDL-C, LDL-C/HDC-C ratio, TC/HDL-C ratio and apolipoprotein (apo) B. 3)to evaluate the safety of ezetimibe/simvastatin (10mg/40mg) versus doubling the statin dose.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Criteria b. Patient has taken a stable daily dose of one of the following medications for the past 3 months: • atorvastatin 10 mg, 20 mg, or 40 mg, or; • pravastatin 10 mg or 20 mg, or; • simvastatin 10 mg, 20 mg, or 40 mg, or; • fluvastatin 20 mg, 40 mg or; • lovastatin 10mg, 20mg or; • rosuvastatin 10mg, 20mg Criteria c. Patient is hospitalized for investigation of a coronary event: • unstable angina pectoris with electrocardiogram changes, or; • increased troponin levels following myocardial infarction, or; • changes in creatine kinase-MB (CKMB) following myocardial infarction. |
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E.4 | Principal exclusion criteria |
a. Patients who are pregnant or lactating. b. Patients who have been treated with any other investigational drug within 3 months of Visit 1. (If < 3 months, contact the Headquarters Clinical Monitor for a case-by-case evaluation.) c. Any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study. d. Congestive heart failure defined by NYHA Class III or IV. e. Uncontrolled hypertension (treated or untreated) with systolic blood pressure > 160 mm Hg or diastolic > 100 mm Hg at Visit 1. f. Type I or Type II diabetes mellitus that is poorly controlled (HbA1c > 9.0%) or newly diagnosed (within 3 months). g. Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e. secondary causes of hyperlipidemia) or secondary hypercholesterolemia due to hypothyroidism, (TSH> ULN) at Visit 1. Note: Patients with a history of hypothyroidism, who is on stable therapy of thyroid hormone replacement for at least 6 weeks, are eligible for enrollment. h. Impaired renal function [creatinine 177 mol/L ( 2.0 mg/dL)] or nephrotic syndrome at Visit 1. i. Disorder of the hematologic, digestive, or central nervous systems including cerebrovascular disease and degenerative disease that would limit study evaluation or participation. j. Patient who is known HIV positive. k. Cancer within the past 5 years (except for an anticipated clinically cured conditions with normal life expectancy). l. History of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy. Prohibited Concomitant Therapies m. Medications that are potent inhibitors of CYP3A4, including cyclosporine or danazol, systemic itraconazole or ketoconazole, erythromycin or clarithromycin, nefazodone, and protease inhibitors, verapamil, diltiazem, and amiodarone. Patients that consume more than one quart of grapefruit juice per day. n. Lipid-lowering agents that include fish oils, Cholestin, bile-acid sequestrants, or niacin (>200 mg/day) taken within 6 weeks and fibrates within 8 weeks prior to randomization at Visit 1. o. Oral corticosteroids (unless used as replacement therapy for pituitary/adrenal disease and on a stable regimen for at least 6 weeks prior to Visit 1).
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the actual LDL-C follow-up value after 12 weeks of treatment.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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 | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
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) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |