EUCTR2004-002345-12-DE进行中（未招募）不适用
An Open-Label, Multicenter Study to Assess the Efficacy of Switching to a Combination tablet Ezetimibe/Simvastatin 10mg/40mg, Compared to Doubling the Dose of Statin in Patients Hospitalized With a Coronary Event
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 490
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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).
研究者
相似试验
进行中（未招募）
1 期
An Open-Label, Multicenter Study to Assess the Efficacy of Switching to a Combination tablet Ezetimibe/Simvastatin 10mg/40mg, Compared to Doubling the Dose of Statin in Patients Hospitalized With a Coronary EventMedDRA version: 7.0 Level: LLT Classification code 10020603hypercholesterolemiaEUCTR2004-002345-12-GB490
进行中（未招募）
不适用
An Open-Label, Multicenter Study to Assess the Efficacy of Switching to a Combination tablet Ezetimibe/Simvastatin 10mg/40mg, Compared to Doubling the Dose of Statin in Patients Hospitalized With a Coronary EventhypercholesterolemiaEUCTR2004-002345-12-ATMerck Sharp & Dohme Gesellschaft m.b.H.490
进行中（未招募）
1 期
An Open-Label, Multicenter Study to Assess the Efficacy of Switching to a Combination tablet Ezetimibe/Simvastatin 10mg/40mg, Compared to Doubling the Dose of Statin in Patients Hospitalized With a Coronary EventHypercolesterolemiaMedDRA version: 6.1 Level: HLT Classification code 10014476EUCTR2004-002345-12-ITMERCK SHARP DOHME450
进行中（未招募）
不适用
An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery - Study 311EUCTR2005-001579-37-SEWyeth Research Division of Wyeth Pharmaceuticals, Inc. Clinical Research and Development50
进行中（未招募）
1 期
An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major SurgeryMale subjects with hemophilia A (FVIII:C =2% confirmed at screening), previously treated with = 150 exposure days to any Factor VIII product, undergoing elective major surgery that is anticipated to require FVIII infusions over a period of at least 6 days following surgeryMedDRA version: 8.1Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIIEUCTR2005-001579-37-FRWyeth Research Division of Wyeth Pharmaceuticals, Inc. Clinical Research and Development50