CTRI/2018/04/013464已完成3 期
A Prospective, Randomized, Double-blind, Double dummy, Multi Centre, Comparative Phase III Clinical Trial to Evaluate the Efficacy and Safety of Ivabradine Prolonged Release Tablets in Patients with Stable Chronic Heart Failure with Systolic Dysfunction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 21
- 主要终点
- To compare change in resting HR from baseline to end of 3 months between Ivabradine PR and Ivabradine IR tablets as assessed by taking 3 consecutive ECGs within 30 minutes by automated standard 12lead ECG
研究概览
简要总结
This is a prospective, randomized, double-blind, double dummy,multicenter, comparative Phase III clinical trial to evaluate the efficacyand safety of Ivabradine PR tablets versus Ivabradine IR tablets in patientswith stable chronic HF with systolic dysfunction.
In addition to above mentionedprimary and secondary endpoints below mentioned exploratory endpoints are assessedduring study.
· Incidencefor hospitalizations for worsening HF, other CV reasons CV mortality, orall-cause mortality from baseline to end of 3 months during the trial
· Tocompare the change in HR (measured by automated 12-lead ECG) versus HR measuredby 24-hour Holter ECG (24-hour, awake, and sleep)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female between 18 to 70 years (both inclusive) 2.Currently receiving stable dose of Ivabradine IR 5 mg /7.5 mg BID since ≥ 1 month for stable chronic HF with systolic dysfunction 3.Concurrently receiving standard care for stable CHF (as per recommendation 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic HF)8 4.Documented stable chronic CHF of NYHA Class II to III ≥ 6 weeks at the time of screening 5.Sinus rhythm with clinically stable HR>50 bpm (both inclusive) as assessed automatically by a standard 12-lead ECG 6.Documented LVEF ≤40 % at screening 7.No physical limitation to ingest and retain oral medication 8.Willingness to participate in the study and provide written informed consent.
排除标准
- •1.History of recent MI, coronary revascularization, stroke, or transient ischemic attack ≤ 3 months), or with a transplanted heart, implanted pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy 2.Scheduled for coronary revascularization, or likely to require surgery for valvular disease during the study period 3.Permanent atrial fibrillation or flutter or any other cardiac arrhythmias which may interfere with function of sinoatrial node 4.Sick sinus syndrome, sinoatrial block, congenital long QT or treated with QT prolonging medications, 2nd degree and complete atrioventricular block 5.Stroke or transient cerebral ischemia within previous ≤ 3 months prior at screening 6.Unstable or acute HF, unstable angina 7.Severe or uncontrolled hypertension (systolic BP [SBP] ≥ 190 mmHg or diastolic BP [DBP] ≥ 110 mmHg) uncontrolled hypotension (SBP ≤ 90 mmHg or DBP ≤ 50 mmHg) 8.History of frequent hypoglycemia within ≤3 months at screening 9.Hospitalization for worsening HF (NYHA class II or higher) ≤ 3 months at screening 10.Any cardiac condition which does not justify the inclusion of the patient in the study as per investigator discretion (e.g. severe primary valvular disease, active myocarditis, congenital heart disease, peripartum cardiomyopathy, etc.) 11.Patient having the following laboratory results at screening: a.Hemoglobin (Hb) men <11 g/dL, women <10 g/dL b.ALT/AST levels ≥ 3 Ñ… ULN c.eGFR<15 mL/min 12.Women who are, pregnant, nursing, or planning to become pregnant or who are of childbearing potential not willing to implement appropriate contraceptive measures or who are considering to stop appropriate use of contraception during the study period 13.Contraindication to Ivabradine or its excipients; or Ivabradine not recommended or known to be not effective, or requirement for a not recommended concomitant treatment (as per ProcoralanIvabradine prescribing information and SPC of Procoralan®) 14.History of psychiatric disorders which may interfere with patient’s ability to understand or complete requirements of the study 15.Any other illness or conditions that does not justify patient’s participation in the study as judged by the investigator (E.g. Alcohol abuse, chronic illness like memory loss, Alzheimer’s etc) 16.Is currently participating in any other clinical trial or has participated in any other clinical trial 3 months prior to screening 17.Not willing to comply with all aspects of the protocol.
结局指标
主要结局
To compare change in resting HR from baseline to end of 3 months between Ivabradine PR and Ivabradine IR tablets as assessed by taking 3 consecutive ECGs within 30 minutes by automated standard 12lead ECG
时间窗: Baseline to end of 03 month
次要结局
- Treatment emergent adverse events (TEAEs) during the study (including nature, severity, and frequency(03 Month)
研究者
研究点 (21)
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