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

NCT01327014 | Completed Phase 2

• 1 other identifier: WPU-201
• Study Type: interventional
• Target: 116
• Locations: 2 countries
• Sites: 13

Brief 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.

Conditions

Hyperlipidemia

Keywords

Hyperlipidemia; Cholesterol; Lipids; Lipoproteins; XueZhiKang; Botanical

Outcome Measures

Primary Outcomes (1)

• Mean percentage change from baseline at week 12 (or the last assessment) on serum low-density lipoprotein cholesterol (LDL-C) level.

  Screening, Baseline, Week 4, Week 6, and Week 12

Secondary Outcomes (8)

• Mean percentage change from baseline at week 12 (or the last assessment on serum total cholesterol (TC) level.

  Screening, Baseline, Week 4, Week 6, and Week 12

• Mean percentage change from baseline at week 12 (or the last assessment) on serum high-density lipoprotein cholesterol (HDL-C) level

  Screening, Baseline, Week 4, Week 6, and Week 12

• Mean percentage change from baseline at week 12 (or the last assessment) on serum triglyceride (TG) level.

  Screening, Baseline, Week 4, Week 6, and Week 12

• Mean percentage change from baseline at week 12 (or the last assessment) on serum non-HDL cholesterol level.

  Screening, Baseline, Week 4, Week 6, and Week 12

• 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.

  Screening, Baseline, Week 4, Week 6, and Week 12

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

1,200 mg/day of XZK group

EXPERIMENTAL

Drug: XueZhiKang (XZK), a botanic product with multiple components

2,400 mg/day of XZK group

EXPERIMENTAL

Drug: XueZhiKang (XZK), a botanic product with multiple components

Interventions

XueZhiKang (XZK), a botanic product with multiple components DRUG

4 capsules of study drug twice a day for 12 weeks.

1,200 mg/day of XZK group; 2,400 mg/day of XZK group

Placebo DRUG

4 capsules twice a day for 12 weeks.

Placebo group

Eligibility Criteria

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

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.

Sponsors & Collaborators

• Beijing Peking University WBL Biotech Co., Ltd.: lead

Study Sites (13)

Robert Karns, MD A Medical Corporation

Beverly Hills, California, 90211, United States

Location

Jellinger and Lerman, MD

Hollywood, Florida, 33021, United States

Location

Department of Internal Medicine, University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Harold E Bays, MD

Louisville, Kentucky, 40213, United States

Location

Eli M Roth, MD

Cincinnati, Ohio, 45219, United States

Location

Cardiovascular Medical Associates

Philadelphia, Pennsylvania, 19107, United States

Location

Osvaldo Brusco, MD

Corpus Christi, Texas, 78404, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Second Xiangya Hospital of Central-South Univ

Changsha, Hunan, 410011, China

Location

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

xuezhikang

Condition Hierarchy (Ancestors)

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

Study Officials

• David Capuzzi

  Cardiovascular Medical Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 30, 2011
• First Posted: April 1, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 23, 2014

Record last verified: 2014-07

Locations

US (8); CN (5)