A clinical trial to study effects of Ivabradine® when given in combination with Atenolol® for patients with Chronic Stable Angina.
- Registration Number
- CTRI/2009/091/000429
- Lead Sponsor
- upin Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 230
•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.
•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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method