A Clinical trial to study the efficacy, safety and tolerability of Carvedilol Phosphate ER 10 mg + Amlodpine 5 mg Capsule Vs Amlodipine 5 mg + Metoprolol 50 mg Tablet in Patients with Mild to severe Heart Failure.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- i)Peripheral edema
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
i)Peripheral edema
时间窗: At base line and end of 2nd, 4th,8th and 12 weeks
2)dyspnea
时间窗: At base line and end of 2nd, 4th,8th and 12 weeks
5)pulmonary rales
时间窗: At base line and end of 2nd, 4th,8th and 12 weeks
3)jugular venous distension 4)nocturnal cough
时间窗: At base line and end of 2nd, 4th,8th and 12 weeks
6)Body weight
时间窗: At base line and end of 2nd, 4th,8th and 12 weeks
7)Ankle circumference
时间窗: At base line and end of 2nd, 4th,8th and 12 weeks
次要结局
- Global assessment of Safety and Tolerability by patients and physicians.(At the end of 12th Week)