Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-02-28

Brief Summary

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

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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

Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo Arm: Placebo 1 tablet bid. p.o

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tablet bid. p.o for 8 weeks

Probucol

Probucol Arm: Imported Probucol 250 mg (1 tablet) bid. p.o

Group Type ACTIVE_COMPARATOR

Probucol

Intervention Type DRUG

250mg (1 tablet) bid. p.o for 8 weeks

Interventions

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Probucol

250mg (1 tablet) bid. p.o for 8 weeks

Intervention Type DRUG

Placebo

1 tablet bid. p.o for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Lorelco

Eligibility Criteria

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Inclusion Criteria

1. Signing Informed Content Form;
2. Age \>= 20 (the age at the time of signing ICF; both gender);
3. 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);
4. Framingham: Coronary Heart Disease 2-year risk probabilities \< 10%.

Exclusion Criteria

1. Subjects who receive antilipemic agents within 1 month prior to the pre-screening period;
2. Subjects who receive Probucol within 6 months prior to the pre-screening period;
3. Coronary Heart Disease subjects;
4. Subjects being treated with cyclosporine;
5. Subjects with a history of hypersensitivity to Probucol;
6. QTc interval \> 450ms (male); QTc interval \> 470ms (female);
7. 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
8. Female subjects who are pregnant, lactating, or who plan to conceive;
9. Subjects who are considered by the investigator to be inappropriate to participate in this trial.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No