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Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

Sponsor
Otsuka Beijing Research Institute (Industry)
Overall Status
Completed
CT.gov ID
NCT01349010
Collaborator
(none)
264
Enrollment
1
Location
2
Arms
22.1
Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
264 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double Blind, Placebo Control, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Imported Probucol in Hyperlipidemia Patients
Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placebo Arm: Placebo 1 tablet bid. p.o

Drug: Placebo
1 tablet bid. p.o for 8 weeks
Active Comparator: Probucol

Probucol Arm: Imported Probucol 250 mg (1 tablet) bid. p.o

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. TC and LDL-C [8-week]

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

    Secondary Outcome Measures

    1. oxLDL and MCP-1 [8-week]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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);

    1. 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

    1. Female subjects who are pregnant, lactating, or who plan to conceive;

    2. Subjects who are considered by the investigator to be inappropriate to participate in this trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Sencond Xiangya Hospital of Central South University Changsha Hunan China 410011

    Sponsors and Collaborators

    • Otsuka Beijing Research Institute

    Investigators

    • Principal Investigator: Shuiping Zhao, MD, The Sencond Xiangya Hospital of Central South University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Otsuka Beijing Research Institute
    ClinicalTrials.gov Identifier:
    NCT01349010
    Other Study ID Numbers:
    • 009-10-802-01
    First Posted:
    May 6, 2011
    Last Update Posted:
    Jun 5, 2013
    Last Verified:
    Jun 1, 2013
    Keywords provided by Otsuka Beijing Research Institute
    hyperlipidemia
    Additional relevant MeSH terms:
    Hyperlipidemias
    Hyperlipoproteinemias
    Probucol

    Study Results

    No Results Posted as of Jun 5, 2013