Study on the Efficacy and Safety of Oral Probucol Tablets in Patients With Hyperlipidemia - Post-Marketing Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,087
- 主要终点
- Efficacy - Improvement in serum lipids.
研究概览
简要总结
The primary objective of this post marketing surveillance (PMS) is to determine the safety and efficacy of probucol in lowering the level of serum cholesterol in the blood.
详细描述
This nationwide post marketing surveillance targets to recruit a total of 3,000 patients with hyperlipidemia. Duration of treatment is 60 days. The usual starting dose for Lorelco is 500 mg administered daily, divided into two (2) doses (250mg BID) and given after meals. The dose may be adjusted according to the patient's age and condition. Lipid serum test will be obtained at Day 0 (Baseline). In subjects requiring antihyperlipidemics that fulfill the inclusion criteria, Lorelco 250 BID will be started. There will be 2 follow-up visits after baseline on Day 30 and Day 60. Both lipid serum tests and ECG will be done on these 2 follow-up visits. During each visit the investigator will assess the subject's vital signs and symptoms and check for any adverse events.
The primary outcome of measure is the percentage reduction or increase in total cholesterol and triglycerides from baseline values at Week 0 to Week 4 and Week 8 using the following scale:
Total Cholesterol Triglycerides
- Markedly reduced
- Moderately reduced
- Slightly reduced
- Unchanged
- Increased Reduction of ≥ 15% Reduction of ≥ 10% but < 15% Reduction of ≥ 5% but < 10% Change of < 5% Increase of ≥ 5% Reduction of ≥ 30% Reduction of ≥ 20% but < 30% Reduction of ≥ 10% but < 20% Change of < 10% Increase of ≥ 10% The percentage change on the last week of treatment will be the final evaluation.
The secondary outcome is measured by the changes in symptoms and vital signs. Using the following scale:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with hyperlipidemia including familial hypercholesterolemia and xanthoma.
排除标准
- 未提供
结局指标
主要结局
Efficacy - Improvement in serum lipids.
时间窗: values will be calculated at Day 60
Percentage changes in total cholesterol and triglycerides from
次要结局
- Efficacy - Changes in symptoms and vital signs.(overall 60 days)
- Safety - Overall Safety will be evaluated to assess the usefulness of the study drug(overall 60 days)
