Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Beijing Research Institute
• Treatments: Probucol

Criteria

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.