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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beijing Peking University WBL Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01327014
First received: March 30, 2011
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
Drug: XueZhiKang (XZK), a botanic product with multiple components
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Lipid-Lowering Effects of XueZhiKang (XZK) in Patients With Hyperlipidemia

Resource links provided by NLM:


Further study details as provided by Beijing Peking University WBL Biotech Co., Ltd.:

Primary Outcome Measures:
  • Mean percentage change from baseline at week 12 (or the last assessment) on serum low-density lipoprotein cholesterol (LDL-C) level. [ Time Frame: Screening, Baseline, Week 4, Week 6, and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean percentage change from baseline at week 12 (or the last assessment on serum total cholesterol (TC) level. [ Time Frame: Screening, Baseline, Week 4, Week 6, and Week 12 ] [ Designated as safety issue: No ]
  • Mean percentage change from baseline at week 12 (or the last assessment) on serum high-density lipoprotein cholesterol (HDL-C) level [ Time Frame: Screening, Baseline, Week 4, Week 6, and Week 12 ] [ Designated as safety issue: No ]
  • Mean percentage change from baseline at week 12 (or the last assessment) on serum triglyceride (TG) level. [ Time Frame: Screening, Baseline, Week 4, Week 6, and Week 12 ] [ Designated as safety issue: No ]
  • Mean percentage change from baseline at week 12 (or the last assessment) on serum non-HDL cholesterol level. [ Time Frame: Screening, Baseline, Week 4, Week 6, and Week 12 ] [ Designated as safety issue: No ]
  • Mean percentage change from baseline at week 12 (or the last assessment) on serum apolipoprotein A-I (Apo A-I) and serum apolipoprotein-B (Apo-B) and the Apo-B/Apo A-I ratio. [ Time Frame: Screening, Baseline, Week 4, Week 6, and Week 12 ] [ Designated as safety issue: No ]
  • Mean percentage change from baseline at week 12 (or the last assessment) on the serum TC/HDL-C ratio. [ Time Frame: Screening, Baseline, Week 4, Week 6, and Week 12 ] [ Designated as safety issue: No ]
  • Percentage of patients who show a LDL-C level of <130 mg/dl or <100 mg/dl at end of the study. [ Time Frame: Screening, Baseline, Week 4, Week 6, and Week 12 ] [ Designated as safety issue: No ]
  • Safety will be assessed by the incidence of adverse events (AEs), discontinuation due to the AEs, clinically relevant changes on laboratory test results, vital signs, physical examinations, and 12-lead electrocardiograms (ECG). [ Time Frame: Screening, Baseline, Week 4, Week 6, and Week 12; ECG and Physical exam only at Screening and Week 12. ] [ Designated as safety issue: Yes ]

Enrollment: 116
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo group Drug: Placebo
4 capsules twice a day for 12 weeks.
Experimental: 1,200 mg/day of XZK group Drug: XueZhiKang (XZK), a botanic product with multiple components
4 capsules of study drug twice a day for 12 weeks.
Experimental: 2,400 mg/day of XZK group Drug: XueZhiKang (XZK), a botanic product with multiple components
4 capsules of study drug twice a day for 12 weeks.

Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Patients with a 10-year coronary heart disease risk Framingham Point Score of < 10%.
  3. Male or female patients, of any race, at least 18 years of age.
  4. 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.
  5. Patients must have been informed of all aspects of the study and signed an informed consent form before any study-related activities.
  6. Patients must be willing to follow the TLC diet.
  7. BMI < 36 kg/m2.
  8. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. Patients with myocardial infarction, stroke, transient ischemic attack, cardiovascular surgery or major operations within 6 months prior to screening visit.
  2. Patients with percutaneous coronary intervention within 3 months.
  3. Patients who have been taken lipid-lowering medications including statins or XZK during the 4 weeks prior to screening visit.
  4. 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.
  5. Patients who are taking anticoagulants except aspirin at < 325 mg/day.
  6. 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.
  7. Patients with elevated creatine phosphokinase level (above Upper Limit of Normal range).
  8. Patients with renal dysfunction as indicated by a serum creatinine level above ULN range, or clinical symptoms.
  9. Patients with gastric or peptic ulcer within 3 months prior to screening visit.
  10. Patients with uncontrolled diabetes mellitus as defined by a HbA1c level of > 7.0%.
  11. 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.
  12. Patients with clinically relevant illness within 4 weeks prior to the screening visit that may interfere with the conduct of this study.
  13. Patients with a history of alcohol or narcotic substance abuse within two years prior to screening visit.
  14. Patients with hypersensitivity to lipid-lowering agents.
  15. Patients who have taken another investigational drug within 4 weeks prior to screening visit.
  16. Patients with uncontrolled metabolic or endocrine disease knowing to influence lipid values.
  17. Patients who are known to be HIV positive.
  18. 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.
  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: NCT01327014

Locations
United States, California
Robert Karns, MD A Medical Corporation
Beverly Hills, California, United States, 90211
United States, Florida
Jellinger and Lerman, MD
Hollywood, Florida, United States, 33021
United States, Kansas
Department of Internal Medicine, University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
Harold E Bays, MD
Louisville, Kentucky, United States, 40213
United States, Ohio
Eli M Roth, MD
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Cardiovascular Medical Associates
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Osvaldo Brusco, MD
Corpus Christi, Texas, United States, 78404
Clinical Trial Network
Houston, Texas, United States, 77074
China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
China, Hubei
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
China, Hunan
Second Xiangya Hospital of Central-South Univ
Changsha, Hunan, China, 410011
China, Shanghai
Shanghai First People's Hospital
Shanghai, Shanghai, China, 200080
Shanghai Ruijin Hospital
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Beijing Peking University WBL Biotech Co., Ltd.
Investigators
Principal Investigator: David Capuzzi Cardiovascular Medical Associates
  More Information

No publications provided

Responsible Party: Beijing Peking University WBL Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01327014     History of Changes
Other Study ID Numbers: WPU-201
Study First Received: March 30, 2011
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Beijing Peking University WBL Biotech Co., Ltd.:
Hyperlipidemia
Cholesterol
Lipids
Lipoproteins
XueZhiKang
Botanical

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014