CTRI/2009/091/001022已完成3 期
An open label multicentric study to assess the efficacy and safety of Atorvastatin + Ramipril + Aspirin + Metoprolol (as extended release) fixed dose combination capsules for secondary prophylaxis in patients with ischemic heart disease.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients of either sex more than or equal to 18 years of age (No upper age limit was mentioned in our Protocol for this clinical trial).
- •2.Established diagnosis of ischemic heart disease.
- •3.Informed consent of the patient / relative.
排除标准
- •1.Pregnancy & Lactation.
- •2.Patients with active liver disease or hepatic dysfunction indicated by AST or ALT levels 2.5 times the upper limit of normal.
- •3.Patients with history of myopathy or evidence of active muscle disease.
- •4.Patients with congestive heart failure (defined as New York Heart Association class III or IV heart failure).
- •5.Patients with 2nd or 3rd degree AV block, sick sinus syndrome or uncontrolled cardiac arrhythmias.
- •6.Patients with active peptic ulceration, hemophilia or hemorrhagic disorders.
- •7.Patients with unstable endocrine or metabolic diseases known to influence serum lipids and lipoproteins or known impairment of renal function.
- •8.Patients with any other serious concurrent illness or malignancy.
- •9.Patients with continuing history of alcohol and / or drug abuse.
- •10.Patients with known hypersensitivity to either of the contents of the combination.
- •11.Participation in another clinical trial in the past 3 months.
研究者
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