Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

Otsuka

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia

Treatments: Drug: Placebo; Drug: Probucol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01349010

009-10-802-01

Details and patient eligibility

About

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

Full description

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

Enrollment: 264 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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264 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo Arm: Placebo 1 tablet bid. p.o

Treatment:

Drug: Placebo

Probucol

Active Comparator group

Description:

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

Treatment:

Drug: Probucol