[EFFECTS OF SELECTED STATINS ON CARDIOVASCULAR PARAMETERS IN HEALTHY VOLUNTEERS: A RANDAMOZIED PHASE I CLINICAL TRIAL]
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Blood Pressure Measurements
研究概览
简要总结
This study is a Phase I randomized clinical trial aiming to investigate the short-term effects of three commonly prescribed statins i.e (Atorvastatin, Rosuvastatin, and Simvastatin) at different dose levels i.e lo,median and high doses on cardiovascular parameters i.e Blood pressure and ECG morphology in healthy volunteers. The study will assess changes in blood pressure and ECG morphology following two days of statin administration under controlled conditions.
详细描述
The goal of this study is to evaluate the effects of these three statins on the cardiovascular parameters in a dose-dependent manner. In this Phase 1 clinical trial we will enroll healthy volunteers who will be randomized to receive one of three statins at low, moderate, or high doses for two days. .
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The PI will give the assigned medication to each participant according to randomization and allocation. All the personnel involved in the study will be kept blind.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Normal ECG
- •Normal Blood Pressure
- •Normal lipid levels
排除标准
- •Participants with a history of diabetes mellitus,BP
- •With chronic diseases e.g heart disease, kidney disease
- •QTc ≥450 ms (men) or ≥470 ms (women)
- •ECG changes
- •Electrolyte imbalance,
- •Participants taking other medications
研究组 & 干预措施
Rosuvastatin (5mg, 20mg, 40mg)
The assigned participants will be given Rosuvastatin 5mg, 20mg, 40mg OD for two days
干预措施: Rosuvastatin (5mg, 20mg, 40mg) (Drug)
Atorvastatin (10mg,20mg, 40mg)
The assigned participants will be given Atorvastatin 10mg,20mg, 40mg OD for two days
干预措施: Atorvastatin (10mg, 20mg, 40mg) (Drug)
Simvastatin (10mg, 20mg, 40mg)
The assigned participants will be given Simvastatin 10mg, 20mg, 40mg OD for two days
干预措施: Simvastatin (10mg, 20mg, 40m (Drug)
结局指标
主要结局
Blood Pressure Measurements
时间窗: before dosing and 2 days after dosing achieving peak plasma concentrations respectively]
Blood Pressure of the subjects will be determined by sphygmomanometer
次要结局
- Electrocardiograms (ECGs) Measurements(before dosing and 2 days after dosing achieving peak plasma concentrations respectively])
研究者
Dr Abid Ullah
Lecturer
Shaheed Benazir Bhutto University Sheringal Dir Upper