EUCTR2007-004448-60-IT进行中（未招募）不适用
A Multicenter, Randomized, Double-Blind, Parallel Arm, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Elderly Patients With Hypercholesterolemia at Moderately High Risk and High Risk for Coronary Heart Disease. - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,275
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
- •Patients with screening values/findings outside the ranges described in the protocol may, at the discretion of the investigator, have one repeat determination performed and if the repeat value satisfies the criterion they may continue in the screening process. Only the specific out of range value/finding should be repeated (not the entire panel, except when a specific lipid test needs to be repeated, then the entire lipid panel should be repeated).
- •1.Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
- •2.Patient is a male or post menopausal female and ≥65 years of age on the day of signing informed consent.
- •3.Patient is willing to maintain a NCEP Therapeutic Lifestyle Changes (TLC)/ADA or similar cholesterol lowering diet for the duration of the study.
- •4.Female patients who are receiving non cyclical hormone therapy (including non cyclical hormone replacement therapy or any estrogen antagonist/agonist) have been maintained on a stable dose and regimen for at least 8 weeks prior to Visit 1 (Week -3) and patient is willing to continue the same regimen throughout the study.
- •5.Patient meets one of the following criteria:
- •oTherapy naïve patients who are at high risk for CHD with established coronary and other atherosclerotic vascular disease or,
- •Note: Established atherosclerotic vascular disease includes history of myocardial infarction, stable angina, coronary artery procedures (angioplasty or bypass surgery) or evidence of clinically significant myocardial ischemia. Other atherosclerotic vascular disease includes clinical manifestations of noncoronary forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and carotid artery disease [transient ischemic attacks or stroke of carotid origin or >50% obstruction of a carotid artery]).
- •Therapy naïve is defined as not being treated with a lipid lowering agent within 6 weeks (8 weeks if a fibrate) prior to Visit 2 (Week -1).
- •oTherapy naïve patients who are at high risk for CHD without atherosclerotic vascular disease who have diabetes or,
- •oTherapy naïve patients who are at high risk for CHD without atherosclerotic vascular disease or diabetes with ≥2 risk factors and a 10-year risk for CHD >20% (as determined by the Framingham calculation, see Appendix 6.4) or,
- •oTherapy naïve patients, or patients rendered naïve by the appropriate prior washout, who are at moderately high risk for CHD with ≥2 risk factors and a 10-year risk for CHD 10-20% (as determined by the Framingham calculation, see Appendix 6.4).
- •Note: Patients rendered naïve is defined as washed out of a lipid lowering agent for 6 weeks (8 weeks if a fibrate) prior to Visit 2 (Week -1).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •1.Patient weighs < 100 lbs (45 kg).
- •2.Patient has hypersensitivity or intolerance to ezetimibe, simvastatin or atorvastatin or any component of these medications, or has a history of significant myopathy or rhabdomyolysis with ezetimibe or any statin.
- •3.Patient routinely consumes more than 2 alcoholic drinks per day.
- •4.Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
- •5.Patient has taken torcetrapib alone or in combination and the last dose was within 1 year of Visit 1.
- •Note: To participate in the study, patients who previously participated in a torcetrapib trial must provide documentation that he/she did not receive torcetrapib or that the last dose of torcetrapib was greater than 1 year of Visit 1.
- •6.Patient has exclusionary laboratory values at Visit 1 (Week -3) as listed in the table below:
- •Laboratory TestExclusionary Value
- •liver transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST])> 1.5 X ULN with no active liver disease
- •Creatine kinase (CK)> 2 X ULN
- •7.Patient?s triglycerides (TG) are > 350 mg/dL (3.95 mmol/L) at Visit 2.
- •8.Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia, such as hypothyroidism or hyperthyroidism).
- •Note: A patient with hyper or hypothyroidism is defined by a TSH below the central laboratory's lower limit of the normal reference range or > 20% above the upper limit of the normal reference range at Visit 1. For patients receiving thyroid hormone, there is no lower TSH threshold for entry and the patient must be on a stable dose for ≥6 weeks before the randomization visit. For patients whose TSH is above the entry criteria, thyroid hormone therapy may be adjusted or initiated provided there is time to stabilize the patient and still meet the enrollment timelines. One redraw will be allowed if the original TSH value is less than 40% above or below the reference range, but the patient must meet the criterion upon redraw.
- •9.Patient has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient?s participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
研究者
相似试验
进行中（未招募）
1 期
A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-WeekStudy to Evaluate the Efficacy and Safety ofEzetimibe/Simvastatin Versus Atorvastatin in Patients with MetabolicSyndrome and Hypercholesterolemia at High Risk for CoronaryHeart DiseaseMedDRA version: 8.1Level: LLTClassification code 10020604Term: HypercholesterolemiaHypercholesterolemiaEUCTR2006-006497-17-NL1,120
进行中（未招募）
不适用
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups ofTC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patientswith Major Depressive Disorder Who Exhibit an Inadequate Response toAntidepressant TherapyAdjunct treatment to an antidepressant in patients with Major Depressive Disorder who exhibit an inadequate response to antidepressant therapyMedDRA version: 12.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSEUCTR2010-020140-36-SKAstraZeneca AB2,236
进行中（未招募）
1 期
A Multicenter, Randomized, Double-Blind, Parallel Group, 12-Week Study to Evaluate the Efficacy and Safety of Extended-Release (ER) Niacin/Laropiprant Added to Statin Versus Doubling the Dose of Statin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia. - Extended Release Niacin/Laropiprant – LipidsHypercholesterolemia or Mixed DyslipidemiaMedDRA version: 9.1 Level: LLT Classification code 10020604 Term: HypercholesterolemiaEUCTR2007-002017-39-DKMerck & Co., Inc.1,250
进行中（未招募）
1 期
A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patient with Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease - NDmetabolic syndrome and hypercholesterolemiaMedDRA version: 6.1 Level: SOC Classification code 10007541EUCTR2006-006497-17-ITMERCK SHARP DOHME1,120
进行中（未招募）
不适用
A study to assess the efficacy and safety of TC-5214 as an adjunct therapy in patients with major depressive disorderAdjunct treatment to an antidepressant in patients with Major Depressive Disorder who exhibit an inadequate response to antidepressant therapyMedDRA version: 13.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 13.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2010-019925-33-DEAstraZeneca AB940