Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

A Randomized, Double Blind, Placebo Control, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Imported Probucol in Hyperlipidemia Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01349010

Enrollment

264

Registered

2011-05-06

Start date

2011-04-30

Completion date

2013-02-28

Last updated

2013-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia

Keywords

hyperlipidemia

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

Interventions

DRUGProbucol

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

DRUGPlacebo

1 tablet bid. p.o for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
TC and LDL-C	8-week	Changes of TC and LDL-C from the baseline after 8-week treatment;

Secondary

Measure	Time frame	Description
oxLDL and MCP-1	8-week	Changes of oxLDL and MCP-1 from the baseline after 8-week treatment;

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026