Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

NCT01349010 | Completed Phase 3

• 1 other identifier: 009-10-802-01
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperlipidemia

Keywords

hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• TC and LDL-C

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

  8-week

Secondary Outcomes (1)

• oxLDL and MCP-1

  8-week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo Arm: Placebo 1 tablet bid. p.o

Drug: Placebo

Probucol

ACTIVE COMPARATOR

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

Drug: Probucol

Interventions

Probucol DRUG

250mg (1 tablet) bid. p.o for 8 weeks

Also known as: Lorelco

Probucol

Placebo DRUG

1 tablet bid. p.o for 8 weeks

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signing Informed Content Form;
• Age \>= 20 (the age at the time of signing ICF; both gender);
• hyperlipidemia patients who meet the following criteria:
• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

The Sencond Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Probucol

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Shuiping Zhao, MD

  The Sencond Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: May 6, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: February 1, 2013
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

CN (1)