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临床试验/NCT07313124
NCT07313124已完成2 期

The Efficiency and Safety of Single Drug Versus Combinations of Antihyperlipidemic Agents in Treatment of Cardiovascular Diseases

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年12月15日最近更新:
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
66
试验地点
1
主要终点
Creatine Kinase

研究概览

简要总结

The goal of this clinical trial is to study the efficiency and safety of using combinations of antihyperlipidemic agents with a single drug to treat cardiovascular diseases.

The main questions it aims to answer are:

  • Which approach is more effective rosuvastatin monotherapy or rosuvastatin ezetimibe combination antihyperlipidemic for patients with cardiovascular diseases (CVDs)?
  • What medical problems do participants could when taking antihyperlipidemic drugs? Researchers will compare rosuvastatin 20 mg or rosuvastatin ezetimibe10/10mg to see the effectiveness and safety of these drugs in patients with CVDs.

Participants will:

  • Patients will randomize to either rosuvastatin 20 mg or rosuvastatin ezetimibe10/10mg.
  • Patients will be followed up to 12 weeks after starting treatment.
  • All the patients will be subjected to: Full sheet taking, including detailed history and diagnosis of the case, Baseline Aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) tests& after 24 weeks of treatment, Lipid Profile, creatine kinase (CK) test, Creatine kinase-MB (CK-MB) test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults above 18 years, Dyslipidemic patients

排除标准

  • Young people under 18 years old pregnant women lactating women Children Hypersensitivity Renal failure

研究组 & 干预措施

RosUvastatin

Experimental

Patients will receive to rosuvastatin 20 mg

干预措施: rosuvastatin drug (Drug)

rosuvastatin ezetimibe10/10mg.

Active Comparator

Patients will receive rosuvastatin ezetimibe10/10mg.

干预措施: Patients received rosuvastatin ezetimibe10/10mg (Combination Product)

结局指标

主要结局

Creatine Kinase

时间窗: at baseline and after 12 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hasnaa Osama

Lecturer of Clinical Pharmacy, Beni-Suef University, Egypt

Beni-Suef University

研究点 (1)

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