Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349010
• Other study ID #: 009-10-802-01
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2011
• Last updated: June 4, 2013
• Start date: April 2011
• Est. completion date: February 2013

Study information

• Verified date: June 2013
• Source: Otsuka Beijing Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: February 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Probucol
250mg (1 tablet) bid. p.o for 8 weeks
• Placebo
1 tablet bid. p.o for 8 weeks

Locations

Country	Name	City	State
China	The Sencond Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Beijing Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TC and LDL-C	Changes of TC and LDL-C from the baseline after 8-week treatment;	8-week	No
Secondary	oxLDL and MCP-1	Changes of oxLDL and MCP-1 from the baseline after 8-week treatment;	8-week	No