Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier:
NCT01349010
First received: March 24, 2011
Last updated: June 4, 2013
Last verified: June 2013

March 24, 2011
June 4, 2013
April 2011
July 2012   (final data collection date for primary outcome measure)
TC and LDL-C [ Time Frame: 8-week ] [ Designated as safety issue: No ]
Changes of TC and LDL-C from the baseline after 8-week treatment;
Same as current
Complete list of historical versions of study NCT01349010 on ClinicalTrials.gov Archive Site
oxLDL and MCP-1 [ Time Frame: 8-week ] [ Designated as safety issue: No ]
Changes of oxLDL and MCP-1 from the baseline after 8-week treatment;
Same as current
Not Provided
Not Provided
 
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

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyperlipidemia
  • Drug: Probucol
    250mg (1 tablet) bid. p.o for 8 weeks
    Other Name: Lorelco
  • Drug: Placebo
    1 tablet bid. p.o for 8 weeks
    Other Name: Placebo
  • Placebo Comparator: Placebo
    Placebo Arm: Placebo 1 tablet bid. p.o
    Intervention: Drug: Placebo
  • Active Comparator: Probucol
    Probucol Arm: Imported Probucol 250 mg (1 tablet) bid. p.o
    Intervention: Drug: Probucol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
264
February 2013
July 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01349010
009-10-802-01
No
Otsuka Beijing Research Institute
Otsuka Beijing Research Institute
Not Provided
Principal Investigator: Shuiping Zhao, MD The Sencond Xiangya Hospital of Central South University
Otsuka Beijing Research Institute
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP