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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
  Purpose

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


Condition Intervention Phase
Hyperlipidemia
Drug: Probucol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Otsuka Beijing Research Institute:

Primary Outcome Measures:
  • 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;


Secondary Outcome Measures:
  • 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;


Enrollment: 264
Study Start Date: April 2011
Study Completion Date: February 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo Arm: Placebo 1 tablet bid. p.o
Drug: Placebo
1 tablet bid. p.o for 8 weeks
Other Name: Placebo
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

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier: NCT01349010     History of Changes
Other Study ID Numbers: 009-10-802-01
Study First Received: March 24, 2011
Last Updated: June 4, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Otsuka Beijing Research Institute:
hyperlipidemia

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

ClinicalTrials.gov processed this record on November 20, 2014