A clinical Trial to study the efficacy, safety and tolerability of Carvedilol Phosphate ER + Amlodipine Capsule Vs Amlodipine + Metoprolol Tablet in Patients with Mild to severe Heart Failure
- Conditions
- Health Condition 1: I508- Other heart failureHealth Condition 2: null- Patients suffering from Mild to severe Heart Failure
- Registration Number
- CTRI/2011/09/001989
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method i)Peripheral edema <br/ ><br>2)dyspnea <br/ ><br>3)jugular venous distension 4)nocturnal cough <br/ ><br>5)pulmonary rales <br/ ><br>6)Body weight <br/ ><br>7)Ankle circumferenceTimepoint: At base line and end of 2nd, 4th,8th and 12 weeks
- Secondary Outcome Measures
Name Time Method Global assessment of Safety and Tolerability by patients and physicians.Timepoint: At the end of 12th Week