Health Condition 1: I249- Acute ischemic heart disease, unspecified Health Condition 2: null- Mild to severe heart failure of ischemic or cardiomyopathic origin
Conditions
Interventions
Intervention1: Carvedilol Phosphate Extended Release Capsules 80 mg (Test Drug): Once daily for 2 weeks
Control Intervention1: Carvedilol Phosphate Extended Release Capsules 80 mg (Reference Drug): On
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients between 18 and 60 years of age 2. Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. 3. Patient with signs and symptoms of mild to severe heart failure of ischemic or cardiomyopathic origin, diagnosed clinically.
Exclusion criteria
Exclusion criteria: 1. Patients below 18 years of age. 2. History of hypersensitivity to the study drug or related products. 3. Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications. 4. Patients with serum potassium 5.5 meq/L. 5. Patients with type II diabetes with microalbuminuria. 6. Patients with myocardial infractions within last 90 days. 7. Patients with serum creatinine 2.0 mg/dL in males or 1.8 mg/dL in females 8. Patients with creatinine clearance 50 mL/min 9. Significant history or presence of glaucoma, cardiovascular or hematological disease. 10. Any clinical significant illness during the 4 weeks prior to day 1 of this study. 11. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease. 12. Participation in a clinical trial with an investigation drug within 30 days proceeding day 1 of this study. 13. Use of enzyme-modifying drugs within 30 days prior to day 1 of this study. 14. HIV and Australian Antigen positive subjects. 15. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A comparative evaluation of efficacy of Carvedilol Phosphate Extended Release Capsules 80 mg (Test Drug), with Carvedilol Phosphate Extended Release Capsules 80 mg (Reference Drug), in-patients suffering from mild to severe heart failure of ischemic or cardiomyopathic origin. The efficacy parameters will primarily focus on improvement in the clinical signs & symptoms like Lowering of blood pressure, Lowering of Chest Pain, Improvement in Cardiogram and Improvement in stress test resultsTimepoint: 0th Day, 1st week and 2nd week | — |
Secondary
| Measure | Time frame |
|---|---|
| A comparative evaluation of safety & tolerability of Carvedilol Phosphate Extended Release Capsules 80 mg (Test Drug), with Carvedilol Phosphate Extended Release Capsules 80 mg (Reference Drug), in-patients suffering from mild to severe heart failure of ischemic or cardiomyopathic origin.Timepoint: 0th Day, 1st week and 2nd week | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd, Advent
Outcome results
None listed