CTRI/2009/091/000429Other4 期
A Phase IV, multi-centre, open label, comparative, parallel, randomized,observational study to compare the efficacy, safety and tolerability ofIvabradine® 5 mg (titrated to 7.5 mg after Day 30) administered alongwith Atenolol® 50 mg versus Atenolol® 50 mg administered alone inpatients with Chronic Stable Angina
适应症
试验速览
- 阶段
- 4 期
- 状态
- Other
- 入组人数
- 230
- 试验地点
- 3
- 主要终点
- Change in Total Exercise Duration (TED) on Exercise Tolerance Test (ETT) from
研究概览
简要总结
This is a phase IV, multi-centre, open label, comparative, parallel, randomized, observational study to compare the efficacy, safety and tolerability of Ivabradine® 5mg (titrated to 7.5 mg after Day 30) administered along with Atenolol® 50 mg versus Atenolol® 50 mg administered alone in patients with Chronic Stable Angina. A study will be conducted in 3 centres in India. Primary end-point of the study is change in Total Exercise Duration (TED) from baseline to end of treatment on Exercise Tolerance Test (ETT). Secondary end-points of the study are Change in other Exercise Tolerance Test (ETT) parameters including Time to Limiting Angina (TLA), Time to Onset of Angina (TOA), Time to 1-mm ST depression (TST) from Day 0 (Baseline) to Day 90 (End of Treatment), Change in frequency of anginal attacks,Need for anti-anginal rescue medications, Change in Heart Rate as measured in beats per min (bpm) from Day 0 (Baseline) to Day 90 (End of treatment).
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- ••Male or Female patients > 18 years and ≤ 75 years of age.
- ••Patients with Chronic Effort Angina Pectoris for atleast 3 months prior to inclusion.
- ••Patients with Normal Sinus Rhythm on ECG at Screening.
- ••Patients undergoing treatment with Atenolol® or other beta-blocker agents for atleast 3 months.
- ••Patients with Positive Exercise Tolerance Test (ETT) at Screening.
- ••Patients who have signed Written Informed Consent.
排除标准
- ••Male or Female patients < 18 years and > 75 years of age.•Resting Heart Rate of < 60 bpm as shown in ECG •Unstable Angina, Prinzmetal’s Angina or Microvascular Angina.•Recent acute myocardial infarction, coronary bypass surgery (less than 3 months before inclusion) or coronary angioplasty (less than 6 months before inclusion).
- ••Known high-grade left main coronary artery disease that has not been surgically bypassed or mechanically improved.•Patient who cannot perform Exercise Tolerance Test (ETT).
- ••ECG abnormalities that would confound ETT interpretation.•Clinically significant heart disease other than coronary artery disease.
- ••Congestive heart failure stage III or IV NYHA.•Symptomatic hypotension.•Uncontrolled hypertension (systolic blood pressure at rest > 180 mmHg or diastolic blood pressure at rest > 100 mmHg).
- ••Atrial fibrillation, flutter, pacemaker or cardioverter-defibrillator implantation.
- ••Patients with Hepatic disorders (ALT > 3 times normal value).
- ••Patients with Thyroid disorders.•Patients with kidney disorders, renal failure (Serum Creatinine level > 180 µmol/l).
- ••Patients with Anaemia (Haemoglobin < 10 g/l).
- ••Any treatment with unauthorized concomitant medication during the study.
- ••Treatment with Amiodarone® within 3 months prior to selection.
- ••Contraindication to Ivabradine®: Second and third degree atrioventricular block, or sick sinus syndrome.•Contraindication to Atenolol®: Second and third degree heart block, manifested heart failure, cardiogenic shock.•History of any serious infectious disease like Hepatitis B or C, HIV etc.
- ••History of severe psychiatric or behavioural disorders likely to interfere with the study.•History of serious abnormal drug reaction.
- ••History of any ophthalmic abnormality as found during screening.•Pregnant and lactating women.•Patients with other severe disease likely to interfere with the study in the investigator’s judgment.
- ••Use of investigational drug within 30 days of pre-selection, or concurrent therapy with an investigational drug(s).
结局指标
主要结局
Change in Total Exercise Duration (TED) on Exercise Tolerance Test (ETT) from
时间窗: Baseline (Day 0) to End of treatment (Day 90)
次要结局
- •Change in other Exercise Tolerance Test (ETT) parameters including Time to Limiting Angina (TLA), Time to Onset of Angina (TOA), Time to 1-mm ST depression (TST) from Baseline to Day 90 (End of treatment)•Change in Heart Rate as measured in beats per min (bpm) from Day 0 (Baseline) to Day 90 (End of treatment).•Change in frequency of anginal attacks•Change in need for anti-anginal rescue medication
研究者
研究点 (3)
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