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

Phase 3

Not yet recruiting

Conditions: Other heart failure, Patients suffering from Mild to severe Heart Failure,

Registration Number: CTRI/2011/09/001989

Lead Sponsor: Ajanta Pharma Ltd

Brief Summary: This study is a Comparative, Randomized, Open label, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Carvedilol Phosphate ER 10 mg + Amlodipine 5 mg Capsule Vs Amlodipine 5 mg + Metoprolol 50 mg Tablet in Patients with Mild to severe Heart Failure. The Study is proposed to start on 05.09.11. The following primary out come will be measured at baseline, 2nd week, 4th week, 8th week and 12th week: Change in Peripheral edema, dyspnea, jugular venous distension, nocturnal cough and pulmonary rales. Body weight and ankle circumference will be evaluated at each visit. The secondary outcome will be measured at the final visit (12th week) - overall response of clinical cure & overall global assessment (based on total score of signs & symptoms).

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 200

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

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	At base line and end of 2nd, 4th,8th and 12 weeks
2)dyspnea	At base line and end of 2nd, 4th,8th and 12 weeks
5)pulmonary rales	At base line and end of 2nd, 4th,8th and 12 weeks
3)jugular venous distension 4)nocturnal cough	At base line and end of 2nd, 4th,8th and 12 weeks
6)Body weight	At base line and end of 2nd, 4th,8th and 12 weeks
7)Ankle circumference	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.	At the end of 12th Week

Trial Locations

Locations (4): Criticare Superspeciality Hospital
🇮🇳
Thane, MAHARASHTRA, India
Kuvam Clinic
🇮🇳
Adilabad, ANDHRA PRADESH, India
Lifeline Hospital
🇮🇳
Vadodara, GUJARAT, India
Smt. S.C. & Seth D.M. Sarvajanik Hospital & Maternity Home
🇮🇳
Mahesana, GUJARAT, India
Criticare Superspeciality Hospital
🇮🇳Thane, MAHARASHTRA, India
Dr Rajiv Srivastava
Principal investigator
09892490089
rajiv0207@gmail.com