Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

Phase 3

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: Placebo; Drug: Probucol

• Registration Number: NCT01349010
• Lead Sponsor: Otsuka Beijing Research Institute

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2011-03-24
• Study Start: 2011-04
• Study First Submitted QC: 2011-05-05
• Study First Posted: 2011-05-06
• Primary Completion: 2012-07
• Study Completion: 2013-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-04
• Last Update Posted: 2013-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

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%.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Arm: Placebo 1 tablet bid. p.o
Probucol	Probucol	Probucol Arm: Imported Probucol 250 mg (1 tablet) bid. p.o

Primary Outcome Measures

Name	Time	Method
TC and LDL-C	8-week	Changes of TC and LDL-C from the baseline after 8-week treatment;

Secondary Outcome Measures

Name	Time	Method
oxLDL and MCP-1	8-week	Changes of oxLDL and MCP-1 from the baseline after 8-week treatment;

Trial Locations

Locations (1)

The Sencond Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China