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

July 22, 2014 updated by: Beijing Peking University WBL Biotech Co., Ltd.

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Lipid-Lowering Effects of XueZhiKang (XZK) in Patients With Hyperlipidemia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Screening, Baseline, Week 4, Week 6, and Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
Time Frame: Screening, Baseline, Week 4, Week 6, and Week 12
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.
Time Frame: Screening, Baseline, Week 4, Week 6, and Week 12
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.
Time Frame: Screening, Baseline, Week 4, Week 6, and Week 12
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.
Time Frame: Screening, Baseline, Week 4, Week 6, and Week 12
Screening, Baseline, Week 4, Week 6, and Week 12
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
Screening, Baseline, Week 4, Week 6, and Week 12
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
Screening, Baseline, Week 4, Week 6, and Week 12
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.
Screening, Baseline, Week 4, Week 6, and Week 12; ECG and Physical exam only at Screening and Week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Peking University WBL Biotech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Capuzzi, Cardiovascular Medical Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WPU-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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