Health Condition 1: I508- Other heart failure Health Condition 2: null- Patients suffering from Mild to severe Heart Failure
Conditions
Interventions
Intervention1: Carvedilol + Amlodipine: Carvedilol 10mg + Amlodipine 5mg Capsule
Route of Administration: Oral
Once daily for 12 Weeks
Control Intervention1: Amlodipine + Metoprolol: Amlodipine 5mg+ M
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or Female patients with age between 18 & 60 years 2.Patients with clinically diagnosis of Mild to severe Heart Failure 3.Written informed consent to participate to the trial.
Exclusion criteria
Exclusion criteria: 1.Males or females, less than 18 or more than 60 years of age 2.History of hypersensitivity to the study drug or similar class of drug. 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 creatinine greater than 2.5 mg/dl. 5.History of drug dependency, alcohol abuse, or serious neurological or psychological disease. 6.Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study. 7.Use of enzyme-modifying drugs within 30 days prior to day 1 of this study. 8.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 |
|---|---|
| i)Peripheral edema 2)dyspnea 3)jugular venous distension 4)nocturnal cough 5)pulmonary rales 6)Body weight 7)Ankle circumferenceTimepoint: At base line and end of 2nd, 4th,8th and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Global assessment of Safety and Tolerability by patients and physicians.Timepoint: At the end of 12th Week | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd, Advent
Outcome results
None listed