Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

June 4, 2013 updated by: Otsuka Beijing Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

264

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • The Sencond Xiangya Hospital of Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Beijing Research Institute

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

March 24, 2011

First Submitted That Met QC Criteria

May 5, 2011

First Posted (ESTIMATE)

May 6, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 009-10-802-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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