Efficacy and Safety Study of Lipid-Lowering Effects of XueZhiKang (XZK) in Patients With Hyperlipidemia

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

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.

Key facts

Study ID

NCT01327014

Run by

Beijing Peking University WBL Biotech Co., Ltd.

People needed

116

Starts

2011-04-01

Expected to finish

2012-12-01

Last updated by the study team

2014-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have been diagnosed with hyperlipidemia as defined by fasting levels of TC ≥ 240 mg/dl and LDL-C ≥ 160 mg/dl but < 190 mg/dl and TG < 400 mg/dl.
• Patients with a 10-year coronary heart disease risk Framingham Point Score of < 10%.
• Male or female patients, of any race, at least 18 years of age.
• Female patients must be postmenopausal as defined by no menstruation for at least 12 months, or surgically sterilized for at least three months prior to beginning the study, or have a negative pregnancy test and agree to avoid pregnancy during the study and one month after the end of the study by using two reliable methods of contraception.
• Patients must have been informed of all aspects of the study and signed an informed consent form before any study-related activities.
• Patients must be willing to follow the TLC diet.
• BMI < 36 kg/m2.
• Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if…

• Patients with myocardial infarction, stroke, transient ischemic attack, cardiovascular surgery or major operations within 6 months prior to screening visit.
• Patients with percutaneous coronary intervention within 3 months.
• Patients who have been taken lipid-lowering medications including statins or XZK during the 4 weeks prior to screening visit.
• Patients with uncontrolled hypertension at the screening visit. Patients on stable antihypertensive medication may be enrolled provided that the medications and dosage remain stable throughout the study.
• Patients who are taking anticoagulants except aspirin at < 325 mg/day.
• Patients with liver dysfunction as indicated by a serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) level of > 1.5-times of upper limit of normal (ULN) range, or clinical symptoms.
• Patients with elevated creatine phosphokinase level (above Upper Limit of Normal range).
• Patients with renal dysfunction as indicated by a serum creatinine level above ULN range, or clinical symptoms.
• Patients with gastric or peptic ulcer within 3 months prior to screening visit.
• Patients with uncontrolled diabetes mellitus as defined by a HbA1c level of > 7.0%.
• Patients with medical history of hypothyroidism, pancreatitis, cholestasis, nephrotic syndrome, gall bladder disease, or primary biliary cirrhosis. Patients on thyroid replacement therapy at stable doses may be enrolled if clinically euthyroid.
• Patients with clinically relevant illness within 4 weeks prior to the screening visit that may interfere with the conduct of this study.
• Patients with a history of alcohol or narcotic substance abuse within two years prior to screening visit.
• Patients with hypersensitivity to lipid-lowering agents.
• Patients who have taken another investigational drug within 4 weeks prior to screening visit.
• Patients with uncontrolled metabolic or endocrine disease knowing to influence lipid values.
• Patients who are known to be HIV positive.
• Patients who have a history or presence of active malignancy (other than non-melanoma skin cancer) or clinically significant psychiatric, neurological, respiratory, hematological, or other conditions that in the opinion of investigators might interfere with or contraindicate participation of the patients in this study.

Where it is running

• Robert Karns, MD A Medical Corporation — Beverly Hills, California, United States
• Jellinger and Lerman, MD — Hollywood, Florida, United States
• Department of Internal Medicine, University of Kansas Medical Center — Kansas City, Kansas, United States
• Harold E Bays, MD — Louisville, Kentucky, United States
• Eli M Roth, MD — Cincinnati, Ohio, United States
• Cardiovascular Medical Associates — Philadelphia, Pennsylvania, United States
• Osvaldo Brusco, MD — Corpus Christi, Texas, United States
• Clinical Trial Network — Houston, Texas, United States
• Chinese PLA General Hospital — Beijing, Beijing Municipality, China
• Wuhan Union Hospital — Wuhan, Hubei, China
• Second Xiangya Hospital of Central-South Univ — Changsha, Hunan, China
• Shanghai Ruijin Hospital — Shanghai, Shanghai Municipality, China
• Shanghai First People's Hospital — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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