None listed
Conditions
Interventions
Intervention1: Ivabradine: 5mg BD for 30 days,
7.5mg BD for 60 days
Intervention2: Atenolol: 50mg OD for 90 Days
Control Intervention1: Atenolol: 50mg OD for 90 Days
Sponsors
Lupin Limited
Karmic Lifesciences
Eligibility
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: &#8226; Male or Female patients < 18 years and > 75 years of age. &#8226; Resting Heart Rate of < 60 bpm as shown in ECG &#8226; Unstable Angina, Prinzmetal&#8217;s Angina or Microvascular Angina. &#8226; Recent acute myocardial infarction, coronary bypass surgery (less than 3 months before inclusion) or coronary angioplasty (less than 6 months before inclusion). &#8226; Known high-grade left main coronary artery disease that has not been surgically bypassed or mechanically improved. &#8226; Patient who cannot perform Exercise Tolerance Test (ETT). &#8226; ECG abnormalities that would confound ETT interpretation. &#8226; Clinically significant heart disease other than coronary artery disease. &#8226; Congestive heart failure stage III or IV NYHA. &#8226; Symptomatic hypotension. &#8226; Uncontrolled hypertension (systolic blood pressure at rest > 180 mmHg or diastolic blood pressure at rest > 100 mmHg). &#8226; Atrial fibrillation, flutter, pacemaker or cardioverter-defibrillator implantation. &#8226; Patients with Hepatic disorders (ALT > 3 times normal value). &#8226; Patients with Thyroid disorders. &#8226; Patients with kidney disorders, renal failure (Serum Creatinine level > 180 µmol/l). &#8226; Patients with Anaemia (Haemoglobin < 10 g/l). &#8226; Any treatment with unauthorized concomitant medication during the study. &#8226; Treatment with Bepridil® within 7 days prior to selection. &#8226; Treatment with Amiodarone® within 3 months prior to selection. &#8226; Contraindication to Ivabradine®: Second and third degree atrioventricular block, or sick sinus syndrome. &#8226; Contraindication to Atenolol®: Second and third degree heart block, manifested heart failure, cardiogenic shock. &#8226; History of any serious infectious disease like Hepatitis B or C, HIV etc. &#8226; History of severe psychiatric or behavioural disorders likely to interfere with the study. &#8226; History of serious abnormal drug reaction. &#8226; History of any ophthalmic abnormality as found during screening. &#8226; Pregnant and lactating women. &#8226; Patients with other severe disease likely to interfere with the study in the investigator&#8217;s judgment. &#8226; Use of investigational drug within 30 days of pre-selection, or concurrent therapy with an investigational drug(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Total Exercise Duration (TED) on Exercise Tolerance Test (ETT) fromTimepoint: Baseline (Day 0) to End of treatment (Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| &#8226; 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) &#8226; Change in Heart Rate as measured in beats per min (bpm) from Day 0 (Baseline) to Day 90 (End of treatment). &#8226; Change in frequency of anginal attacks &#8226; Change in need for anti-anginal rescue medication Timepoint: | — |
Countries
India
Contacts
Public ContactDr Alok Chaturvedi
General Manager- Medical Services
Outcome results
None listed