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
upin Limited0 个研究点目标入组 230 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- Other
- 发起方
- 入组人数
- 230
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 Bepridil® within 7 days prior to selection.
- ••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).
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