We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01349010
Recruitment Status : Completed
First Posted : May 6, 2011
Last Update Posted : June 5, 2013
Sponsor:
Information provided by (Responsible Party):
Otsuka Beijing Research Institute

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
Hyperlipidemia Drug: Probucol Drug: Placebo 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 Type : Interventional  (Clinical Trial)
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 : April 2011
Primary Completion Date : July 2012
Study Completion Date : February 2013

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 Name: Lorelco



Primary Outcome Measures :
  1. TC and LDL-C [ Time Frame: 8-week ]
    Changes of TC and LDL-C from the baseline after 8-week treatment;


Secondary Outcome Measures :
  1. oxLDL and MCP-1 [ Time Frame: 8-week ]
    Changes of oxLDL and MCP-1 from the baseline after 8-week treatment;



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349010


Locations
China, Hunan
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

Responsible Party: Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier: NCT01349010     History of Changes
Other Study ID Numbers: 009-10-802-01
First Posted: May 6, 2011    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013

Keywords provided by Otsuka Beijing Research Institute:
hyperlipidemia

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Probucol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Antioxidants
Protective Agents
Physiological Effects of Drugs