NCT03768427已完成3 期
A Phase 3 Randomized, Active-comparator-controlled Clinical Study to Evaluate the Efficacy and Safety of Ezetimibe/Atorvastatin Combination Tablet (MK-0653C) as Second Line Lipid Lowering Treatment in Chinese Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 454
- 试验地点
- 30
- 主要终点
- Percent Change From Baseline in LDL-C at Week 12
研究概览
简要总结
This study will evaluate the EZ/Ator fixed-dose combination (FDC) tablet (MK-0653C) as second line Low-Density Lipoprotein - Cholesterol (LDL-C) treatment in Chinese participants. The primary hypothesis is that MK-0653C 10/10 mg is superior to atorvastatin 20 mg in percent change from baseline in LDL-C to 12 weeks after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has hypercholesterolemia diagnosed by investigator according to Chinese Guidelines on Prevention and Treatment of Dyslipidemia in Adults (2016 Edition).
- •Has been stabilized on atorvastatin treatment at 10 mg or 20 mg (or other statins with LDL-C lowering efficacy equivalent to atorvastatin) for at least 4 weeks prior to Visit
- •If female, is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP), or is a WOCBP who has used a contraceptive consistent with local regulations.
- •If male, has used a contraceptive consistent with local regulations.
- •Agrees to maintain a stable diet and stable exercise during the study.
排除标准
- •Has uncontrolled hypertriglyceridemia which needs drug intervention or a fasting triglyceride (TG) value ≥500 mg/dL (4.52 mmol/L).
- •Is currently treated with statin at dose of equivalent LDL-C lowering effect >20 mg atorvastatin.
- •Has active liver disease
- •Has New York Heart Association (NYHA) Class III or IV symptomatic congestive heart failure at Visit
- •Has had uncontrolled cardiac arrhythmias, myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, unstable angina, or stroke within 3 months (12 weeks) prior to Visit
- •Has homozygous familial hypercholesterolemia or has undergone LDL apheresis.
- •Has endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia, e.g., hyper or hypothyroidism, Cushing's syndrome).
- •Has had a gastrointestinal tract bypass, or other significant intestinal malabsorption.
- •Has a history of cancer within the past 5 years from Visit 1 (except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer).
- •Is known to be human immunodeficiency virus (HIV) positive.
- •Has hypersensitivity or intolerance to ezetimibe, atorvastatin, the ezetimibe/atorvastatin combination tablet, or any component of these medications or has a condition or situation, which is described as a contraindication in labeling of EZETROL or Lipitor or may interfere with participation in the study.
- •Has disorders of the hematologic, digestive, or central nervous systems including cerebrovascular disease and degenerative disease that would limit study evaluation or participation.
- •Has a history of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy.
- •Has a history of myopathy or rhabdomyolysis with ezetimibe or any statin.
- •Is a WOCBP who has had a positive urine pregnancy test within 24 hours before the first dose of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Is currently taking medications that are potent modulators of cytochrome P-450 3A4 (CYP3A4) including: cyclosporine, systemically administered azole antifungals (e.g., ketoconazole, fluconazole, and itraconazole), macrolide antibiotics (e.g., clarithromycin, and erythromycin), protease inhibitors (e.g., ritonavir, saquinavir, and lopinavir), grapefruit or juice of grapefruit (200 ml/day for >3 times per week)
- •Is taking any cyclical hormones (e.g., cyclical oral contraceptives, cyclical hormone replacement), including the combination of ethinyl estradiol and norethisterone, or non-cyclical hormones, including non-cyclical hormone replacement therapy (HRT) or any estrogen antagonist/agonist within 8 weeks.
- •Note: If participant has been treated with a stable regimen of non-cyclical HRT for > 8 weeks and agree to continue this regimen for the duration of the trial, concomitant therapy is acceptable.
- •Is receiving treatment with systemic corticosteroids (intravenous, intramuscular and oral steroids).
- •Is treated with psyllium, other fiber-based laxatives, phytosterol margarine, and herbal medicine and/or over the counter (OTC) therapies that are known to affect serum lipids.
- •Note: If participant has been treated with a stable regimen for > 8 weeks and agrees to continue this regimen for the duration of the trial, concomitant therapy is acceptable.
- •Is treated with an anti-obesity drug (e.g. mazindol) within 12 weeks prior to Visit
- •Is treated with warfarin or warfarin-like anticoagulants and has not been on a stable dose with a stable International Normalized Ratio (INR) for at least 6 weeks.
- •Has taken lipid-lowering agents (except probucol) including, Cholestin, bile acid sequestrants, ezetimibe, fibrates or niacin (>200 mg/day), proprotein convertases subtilisin/kexin type 9 (PCSK9) inhibitors within 6 weeks prior to Visit
- •Has taken probucol within 10 weeks prior to Visit
- •Has been treated with any other investigational drug within 30 days.
- •Currently follows an excessive weight reduction diet.
- •Currently engages in a vigorous exercise regimen (e.g., marathon training, body building training) or intends to start training during the study.
研究组 & 干预措施
EZ 10 mg/Ator 10 mg
Experimental
Single oral dose of EZ10mg/Ator10mg FDC tablet once daily (QD) for 84 days
干预措施: EZ 10 mg/Ator 10 mg (Combination Product)
EZ 10 mg/Ator 10 mg
Experimental
Single oral dose of EZ10mg/Ator10mg FDC tablet once daily (QD) for 84 days
干预措施: Placebo for FDC EZ/Ator (Drug)
Atorvastatin 20 mg
Active Comparator
2 atorvastatin 10 mg tablets administered orally, QD for 84 days
干预措施: Atorvastatin (Drug)
Atorvastatin 20 mg
Active Comparator
2 atorvastatin 10 mg tablets administered orally, QD for 84 days
干预措施: Placebo for atorvastatin (Drug)
EZ 10 mg/Ator 20 mg
Experimental
Single oral dose of EZ10mg/Ator20mg FDC tablet QD for 84 days
干预措施: EZ 10 mg/Ator 20 mg (Combination Product)
EZ 10 mg/Ator 20 mg
Experimental
Single oral dose of EZ10mg/Ator20mg FDC tablet QD for 84 days
干预措施: Placebo for FDC EZ/Ator (Drug)
Atorvastatin 40 mg
Active Comparator
2 atorvastatin 20 mg tablets administered orally, QD for 84 days
干预措施: Atorvastatin (Drug)
Atorvastatin 40 mg
Active Comparator
2 atorvastatin 20 mg tablets administered orally, QD for 84 days
干预措施: Placebo for atorvastatin (Drug)
结局指标
主要结局
Percent Change From Baseline in LDL-C at Week 12
时间窗: Baseline (Day 1) and Week 12
Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated.
次要结局
- Percentage of Participants With An Adverse Event (AE)(Up to approximately 17 weeks)
- Number of Participants Who Discontinued From Study Treatment(Up to approximately 15 weeks)
研究者
研究点 (30)
Loading locations...
相似试验
已完成
3 期
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive AdultsHIV-1 InfectionNCT02607930Gilead Sciences631
已完成
3 期
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive AdultsHIV-1 InfectionNCT02607956Gilead Sciences657
已完成
3 期
A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)HypercholesterolemiaNCT02550288Organon and Co309
已完成
3 期
A Study to Evaluate the Effectiveness and Safety of a Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone in Patients With High Blood Pressure Who do Not Achieve Target Blood Pressure Following Treatment With Azilsartan Medoxomil AloneEssential HypertensionNCT01456169Takeda507
已完成
3 期
Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected AdultsHIV-1/HBV Co-InfectionNCT03547908Gilead Sciences244