CTRI/2018/10/016215尚未招募不适用
An observation study to assess safety and efficacy of Tablet NGfenceTM 2.6/6.4 mg (Controlled Release) in patients with Angina
Care Lifescience Private Limited65 个研究点 分布在 1 个国家目标入组 1,365 人开始时间: 2018年1月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,365
- 试验地点
- 65
- 主要终点
- Primary Objective
研究概览
简要总结
This study is observational study and does not include any interventional product or procedure. The purpose of this study is to evaluate safety and efficacy of tablet NGfenceTM in terms of find out frequency of headache, frequency of chest pain and improvement in quality of life. Total study duration is about 06 months.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1Patients with Normal Sinus Rhythm on ECG at Screening 2Patients who have signed Written Informed Consent 3Patients with stable/unstable or Prinzmetals angina for at least 3 months prior to inclusion (mild/moderate/severe) 4Male or Female patients > 18 years and < 75 years of age.
排除标准
- •1Male or Female patients < 18 years and > 75 years of age 2Congestive heart failure stage III or IV NYHA.
- •3Symptomatic hypotension.
- •4Atrial fibrillation, flutter, pacemaker or cardioverter-defibrillator implantation 5History of serious abnormal drug reaction.
- •6Patients with Postural hypotension 7Patients with chronic kidney failure 8History of any serious infectious disease like Hepatitis B or C, HIV etc.
- •9History of severe psychiatric or behavioral disorders likely to interfere with the study.
- •10Patients with other severe disease likely to interfere with the study in the investigators judgment.
- •11Pregnant and lactating women.
结局指标
主要结局
Primary Objective
时间窗: At month 3 and month 6
To assess efficacy of Tablet NGfenceTM by evaluating improvement in following parameter :
时间窗: At month 3 and month 6
1)Frequency of anginal attack
时间窗: At month 3 and month 6
2)Severity of anginal attack
时间窗: At month 3 and month 6
3)Ability to perform physical activity
时间窗: At month 3 and month 6
次要结局
- Secondary Objectives(To assess tolerability of Tablet NGfenceTM by evaluating improvement in following parameter)
研究者
研究点 (65)
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