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The purpose of this study is to evaluate the efficacy and safety of imported Probucol in hyperlipidemia patients.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo Arm: Placebo 1 tablet bid. p.o |
|
| Probucol | Active Comparator | Probucol Arm: Imported Probucol 250 mg (1 tablet) bid. p.o |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probucol | Drug | 250mg (1 tablet) bid. p.o for 8 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| TC and LDL-C | Changes of TC and LDL-C from the baseline after 8-week treatment; | 8-week |
| Measure | Description | Time Frame |
|---|---|---|
| oxLDL and MCP-1 | Changes of oxLDL and MCP-1 from the baseline after 8-week treatment; | 8-week |
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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:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Shuiping Zhao, MD | The Sencond Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sencond Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011341 | Probucol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | 1 tablet bid. p.o for 8 weeks |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |