NCT01464476终止3 期
Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator
Forest Laboratories138 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 240
- 试验地点
- 138
- 主要终点
- Time to first cardiovascular event
研究概览
简要总结
This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have an ICD implanted and a history of ventricular tachycardia, ventricular fibrillation, or an appropriate ICD therapy.
- •Have a left ventricular ejection fraction <= 0.40
排除标准
- •Have New York Heart Association (NYHA) Class IV Congestive Heart Failure (CHF) or have decompensated CHF at the time of randomization;
- •Have unstable angina pectoris or a myocardial infarction within 30 days of randomization;
- •Have a history of Torsade de Pointes or heart transplantation
- •Have chronic atrial fibrillation or atrial fibrillation/flutter, that is not adequately rate controlled in the judgment of the Investigator, at screening;
- •Are currently taking systemic Class I or other Class III antiarrhythmic drugs
- •Are currently taking systemic drugs that prolong the QT interval
- •If female, are currently pregnant or breast feeding, or plan to become pregnant during the course of the study
研究组 & 干预措施
Azimilide
Experimental
Azimilide 75 mg film coated tablets
干预措施: Azimilide Dihydrochloride (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first cardiovascular event
时间窗: 365 days
Time to first unplanned cardiovascular hospitalization, unplanned cardiovascular emergency department visit, or cardiovascular death in patients with an Implantable Cardioverter Defibrillator (ICD)
次要结局
- Time to first all-cause shock by the ICD(365 days)
- Time to first unplanned physician-office visit.(365 days)
研究者
研究点 (138)
Loading locations...
相似试验
已完成
3 期
Safety and Efficacy of Adalimumab in Patients With Active Ankylosing SpondylitisAnkylosing SpondylitisNCT00195819Abbott82
进行中（未招募）
2 期
A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)Myelodysplastic SyndromesNCT05469737Bristol-Myers Squibb230
已完成
3 期
A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail PsoriasisNail PsoriasisPlaque PsoriasisNCT02016482AbbVie217
Unknown
3 期
Trimetazidine in Myocardial Injury After Percutaneous Coronary Intervention in Patients With Angina and DiabetesAngina, UnstableDiabetes MellitusNCT03715582University of Sao Paulo General Hospital120
终止
2 期
A Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Intravenous APD418 in Adult Participants With Heart Failure With Reduced Ejection FractionAcute Heart Failure With Reduced Ejection FractionNCT05139615Pfizer22