Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of imported Probucol in hyperlipidemia patients.

Detailed Description
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This is a randomized, double blind, placebo control, multi-centre clinical study in hyperlipidemia patients. Enrolled subjects will be randomized to the treatment group or control group, and receive Probucol or placebo continuously for 8 weeks; Treatment group: Imported Probucol 250 mg (1 tablet) bid. p.o Control group: Placebo 1 tablet bid. p.o

Official Title
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A Randomized, Double Blind, Placebo Control, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Imported Probucol in Hyperlipidemia Patients

Conditions
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Hyperlipidemia

Intervention / Treatment
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* Drug: Probucol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signing Informed Content Form; Age >= 20 (the age at the time of signing ICF; both gender); hyperlipidemia patients who meet the following criteria: 4.14 mmol/L (160mg/dL) =< LDL-C (Serum low density lipoprotein-cholesterol) < 6 mmol/L (232mg/dL) TG (Serum triglycerides) < 4.5 mmol/L (398mg/dL); Framingham: Coronary Heart Disease 2-year risk probabilities < 10%. Exclusion Criteria: Subjects who receive antilipemic agents within 1 month prior to the pre-screening period; Subjects who receive Probucol within 6 months prior to the pre-screening period; Coronary Heart Disease subjects; Subjects being treated with cyclosporine; Subjects with a history of hypersensitivity to Probucol; QTc interval > 450ms (male); QTc interval > 470ms (female); Subjects with impaired hepatic and renal function, who meet any of the following abnormal value: AST >= 100IU/L ALT >= 100IU/L Serum creatinine >= 1.5mg/dL Female subjects who are pregnant, lactating, or who plan to conceive; Subjects who are considered by the investigator to be inappropriate to participate in this trial.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo Arm: Placebo 1 tablet bid. p.o | Drug: Placebo<br>* 1 tablet bid. p.o for 8 weeks<br>|
| Active Comparator: Probucol<br>Probucol Arm: Imported Probucol 250 mg (1 tablet) bid. p.o | Drug: Probucol<br>* 250mg (1 tablet) bid. p.o for 8 weeks<br>* Other names: Lorelco;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TC and LDL-C | Changes of TC and LDL-C from the baseline after 8-week treatment; | 8-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxLDL and MCP-1 | Changes of oxLDL and MCP-1 from the baseline after 8-week treatment; | 8-week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperlipidemia