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Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Probucol
Placebo
Sponsored by
Otsuka Beijing Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia focused on measuring hyperlipidemia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Sencond Xiangya Hospital of Central South University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Probucol

Arm Description

Placebo Arm: Placebo 1 tablet bid. p.o

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 24, 2011
Last Updated
June 4, 2013
Sponsor
Otsuka Beijing Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01349010
Brief Title
Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Beijing Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
Keywords
hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Arm: Placebo 1 tablet bid. p.o
Arm Title
Probucol
Arm Type
Active Comparator
Arm Description
Probucol Arm: Imported Probucol 250 mg (1 tablet) bid. p.o
Intervention Type
Drug
Intervention Name(s)
Probucol
Other Intervention Name(s)
Lorelco
Intervention Description
250mg (1 tablet) bid. p.o for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 tablet bid. p.o for 8 weeks
Primary Outcome Measure Information:
Title
TC and LDL-C
Description
Changes of TC and LDL-C from the baseline after 8-week treatment;
Time Frame
8-week
Secondary Outcome Measure Information:
Title
oxLDL and MCP-1
Description
Changes of oxLDL and MCP-1 from the baseline after 8-week treatment;
Time Frame
8-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signing Informed Content Form; Age >= 20 (the age at the time of signing ICF; both gender); 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); Framingham: Coronary Heart Disease 2-year risk probabilities < 10%. Exclusion Criteria: Subjects who receive antilipemic agents within 1 month prior to the pre-screening period; Subjects who receive Probucol within 6 months prior to the pre-screening period; Coronary Heart Disease subjects; Subjects being treated with cyclosporine; Subjects with a history of hypersensitivity to Probucol; QTc interval > 450ms (male); QTc interval > 470ms (female); 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 Female subjects who are pregnant, lactating, or who plan to conceive; Subjects who are considered by the investigator to be inappropriate to participate in this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuiping Zhao, MD
Organizational Affiliation
The Sencond Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sencond Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China

12. IPD Sharing Statement

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Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

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