Health Condition 1: null- stable Angina
Conditions
Interventions
Intervention1: Pentalong®: 80 mg twice daily for 12 weeks
Control Intervention1: Placebo: twice daily for 12 weeks
Sponsors
Actavis Deutschland GmbH Co KG
Kendle India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: At the end of the run-in period the following inclusion criteria must be fulfilled: 1. Second qualifying ETT meeting all of the following criteria: − Positivity criteria: occurrence of limiting angina and ST-segment depression of at least 1 mm as compared to resting ECG (horizontal or down sloping and persisting for at least 0.08 seconds after J-point, on at least three consecutive complexes) between 2.5 and 12 minutes of initiation with modified Bruce treadmill ergometer protocol. If the ETT is interrupted before reaching positivity for any reason, the patient will not be included. − Stability criteria: Difference between selection (Day -7) and inclusion (Day 0) ETT measurements has to be within 20% of the Day 0 value. 2. At least 4 anginal attacks in the 4 week period preceding randomisation. 3. Compliance to treatment during the run-in period, i.e. placebo on top of background treatment (calculated compliance at least 85%, in addition, patient should not have missed more than one full daily dose). Age limit for the study is 18 years and above
Exclusion criteria
Exclusion criteria: Patients will not be included in the trial if one of the following criteria applies: General exclusion criteria: 1. Incapability of understanding the language in which the information for the patient is given; 2. Presence or history of drug or alcohol abuse; 3. Presence of malignant disease in the past 5 years; 4. The patient is a woman of childbearing potential who does not use a reliable method of contraception; Note: A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. 5. The patient is a pregnant or breast feeding woman; 6. Participation in a concurrent clinical trial or in another trial within the past 4 weeks; 7. Repeated participation in this trial; 8. Anticipated poor medication compliance; 9. The patient is the investigator him/herself. Trial-specific exclusion criteria: 1. Recent acute myocardial infarction, coronary bypass surgery less than 3 months before inclusion or coronary angioplasty less than 6 months before inclusion; 2. Unstable angina, Prinzmetal angina or microvascular angina; 3. Angina pectoris symptoms typically induced by factors other than physical exertion; 4. Known high-grade left main coronary artery disease that has not been surgically bypassed or mechanically improved; 5. History of untreated, clinical relevant mitral insufficiency, constrictive pericarditis, pericardial tamponade, severe pulmonary hypertension, aortic stenosis, hypertrophic obstructive cardiomyopathy or other causes of left ventricular outflow tract obstruction. If such disorders are treated, the treatment should be confirmed by echocardiogram not older than 6 months. The clinical relevance of the disorders is left to the discretion of the investigator; 6. Hyperresponsitivity or contraindications to nitrovasodilators in particular PETN and nitroglycerin; 7. Anticipated elective percutaneous transluminal coronary angioplasty (PTCA) in the upcoming 12 weeks; 8. Patient who cannot perform exercise tests, in particular for muscular, joint and/or skeletal reasons; 9. Clinically significant heart disease other than coronary artery disease; 10. Congestive heart failure stage III or IV New York heart association (NYHA); 11. Symptomatic hypotension (100mmHg, dizziness, orthostatic dysregulation); 12. Uncontrolled hypertension (systolic blood pressure at rest at above 180 mmHg or diastolic blood pressure at rest above 100 mmHg); 13. Atrial fibrillation, flutter, pacemaker or cardioverter-defibrillator implantation; 14. ECG abnormalities that would confound ETT interpretation; 15. Repolarisation disturbance seen in the ECG at baseline; 16. Hepatic disorders (alanine aminotransferase [ALT] more than 3 times normal value), renal failure (serum creatinine level above 180 μmol/l); 17. Electrolyte disorders; 18. Anaemia (haemoglobin below 10.0 mg/dl); 19. Thyroid disorders (unless stable and controlled by thyroxin treatment for at least 3 months); 20. Any treatment with unautho
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Total Exercise Duration (TED) [seconds]) from baseline with PETN 80 mg bid as compared to placebo bid assessed in the trough between the morning and the midday dose, (i.e. at 5 h after intake of morning dose of study medication).Timepoint: after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Angina attack frequencyTimepoint: according to patient diary;Angina attack intensity and durationTimepoint: according to patient diary;Borg scaleTimepoint: Secondary efficacy endpoints;Change in exercise capacity (METs)Timepoint: after 6 and 12 weeks of treatment;Change in HRQoL scores using SAQ and EQ-5DTimepoint: after 12 weeks of treatment;Change in TED (seconds) during ETTTimepoint: after 6 weeks of treatment;Change in time to 1 mm ST segment depression (TST) (horizontal or downsloping for more than 0.08 s after the J point)Timepoint: after 6 and 12 weeks of treatment;Change in time to onset of anginal pain on ETTTimepoint: after 6 and 12 weeks of treatment;Change in TLA (seconds) during ETTTimepoint: after 6 and 12 weeks of treatment;Concomitant use of short-acting nitratesTimepoint: according to patient diary | — |
Countries
Belarus, Georgia, Germany, Hungary, Iceland, India, Poland, Romania, Russian Federation, Serbia, Spain
Contacts
Public ContactVivek Malhotra
Kendle India
Outcome results
None listed