HyperlipidemiaPhase 2NCT01327014
Efficacy and Safety Study of Lipid-Lowering Effects of XueZhiKang (XZK) in Patients With Hyperlipidemia
A Phase 2 study testing XueZhiKang (XZK), a botanic product with multiple components in people with Hyperlipidemia, run by Beijing Peking University WBL Biotech Co., Ltd. at 13 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- XueZhiKang (XZK), a botanic product with multiple components
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Apr 2011to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States8 sites
Robert Karns, MD A Medical Corporation
Beverly Hills, California, 90211
Eli M Roth, MD
Cincinnati, Ohio, 45219
Osvaldo Brusco, MD
Corpus Christi, Texas, 78404
Jellinger and Lerman, MD
Hollywood, Florida, 33021
Clinical Trial Network
Houston, Texas, 77074
Department of Internal Medicine, University of Kansas Medical Center
Kansas City, Kansas, 66160
Harold E Bays, MD
Louisville, Kentucky, 40213
Cardiovascular Medical Associates
Philadelphia, Pennsylvania, 19107
China5 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Second Xiangya Hospital of Central-South Univ
Changsha, Hunan, 410011
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080
Wuhan Union Hospital
Wuhan, Hubei, 430022
About this study
Official title: 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.
Read the 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).
- Conditions
- Hyperlipidemia
- Being tested
- XueZhiKang (XZK), a botanic product with multiple components, Placebo
- Keywords
- Hyperlipidemia, Cholesterol, Lipids, Lipoproteins, XueZhiKang, Botanical
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XueZhiKang (XZK), a botanic product with multiple componentsDrug
4 capsules of study drug twice a day for 12 weeks.
PlaceboDrug
4 capsules twice a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
| 1,200 mg/day of XZK group | Experimental | Not described Receives: Drug: XueZhiKang (XZK), a botanic product with multiple components |
| 2,400 mg/day of XZK group | Experimental | Not described Receives: Drug: XueZhiKang (XZK), a botanic product with multiple components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percentage change from baseline at week 12 (or the last assessment) on serum low-density lipoprotein cholesterol (LDL-C) level.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Screening, Baseline, Week 4, Week 6, and Week 12; ECG and Physical exam only at Screening and Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Peking University WBL Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Capuzzi, Principal investigator, Cardiovascular Medical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327014
- Sponsor's protocol ID
- WPU-201
- Status last verified
- Jul 2014
- First submitted
- 30 Mar 2011
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Lipid-Lowering Effects of XueZhiKang (XZK) in Patients With Hyperlipidemia
- ClinicalTrials.gov ID
- NCT01327014
- Acronym / sponsor ID
- WPU-201
- Conditions
- Hyperlipidemia
- Keywords
- Hyperlipidemia, Cholesterol, Lipids, Lipoproteins, XueZhiKang, Botanical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Beijing Peking University WBL Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XueZhiKang (XZK), a botanic product with multiple components4 capsules of study drug twice a day for 12 weeks. | Drug | 1,200 mg/day of XZK group, 2,400 mg/day of XZK group |
| Placebo4 capsules twice a day for 12 weeks. | Drug | Placebo group |
Primary outcome
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
8 secondary outcomes
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
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
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
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
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
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Capuzzi principal investigator
Cardiovascular Medical Associates
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XueZhiKang (XZK), a botanic product with multiple components in people with Hyperlipidemia, run by Beijing Peking University WBL Biotech Co., Ltd. at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.