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Clinical Trial Summary

The purpose of this study is to demonstrate the efficacy of XueZhiKang to improve plasma lipid profile, as compared to placebo, in outpatients with hyperlipidemia.


Clinical Trial Description

This is a multi-center, double-blind, randomized, placebo-controlled, parallel group study to be conducted in approximately 120 patients with hyperlipidemia in approximately 10 sites in US and China. Patients who satisfy the entry criteria at screening visit will have a 4-week Therapeutic Lifestyle Changes (TLC) diet control period during which all lipid-lowering medications will be discontinued. After the 4-week diet control period, eligible patients will be randomized to one of three treatment groups. The treatment period will last for 12-weeks. Patients will have blood samples collected at 5 time points (screening, baseline, Week 4, Week 8, and Week 12). ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01327014
Study type Interventional
Source Beijing Peking University WBL Biotech Co., Ltd.
Contact
Status Completed
Phase Phase 2
Start date April 2011
Completion date December 2012

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