Efficacy And Safety Of Bococizumab For Lipid Lowering In Asian Hypercholesterolemia Subjects
NCT02947334
Last updated date
ABOUT THIS STUDY
This study is a Phase 3, double blind, placebo controlled, randomized, stratified, parallel
group, multi-center clinical trial designed to compare the efficacy and safety of bococizumab
150 mg SC Q2wks to placebo for LDL-C lowering in subjects with primary hyperlipidemia or
mixed dyslipidemia at high or very high risk for CV events. The study will enroll a total of
approximately 750 subjects from 4 - 5 Asian countries/areas (including China mainland); of
which approximately 600 subjects will be from sites in China. Subjects will be randomized
into a bococizumab treatment arm and a placebo arm in a 1:1 ratio.
Study Location
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing, 100029, China
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Primary Hyperlipidemia or Mixed Dyslipidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Males and females at the age or over 18 years of age.
- With primary hyperlipidemia or mixed dyslipidemia.
- Treated with stable daily dose of statins
- At high or very high risk of incurring a CV event
- Fasting LDL-C >=70 mg/dL (1.81 mmol/L) for subjects on the highest approved dose of statins; Fasting LDL C >=77 mg/dL (1.99 mmol/L) for subjects not on highest approved dose.
- Fasting TG ≤400 mg/dL (4.51 mmol/L)
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Prior exposure to bococizumab or other investigational PCSK9 inhibitor
- NYHA class IV, or Left Ventricular Ejection Fraction <25%
- Poorly controlled hypertension
- History of hemorrhagic stroke or lacunar infarction resulting in a stroke
- Untreated hyperthyroidism or TSH >1 × ULN
- Undergoing apheresis or have planned start of apheresis.
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Primary Hyperlipidemia or Mixed DyslipidemiaEfficacy And Safety Of Bococizumab For Lipid Lowering In Asian Hypercholesterolemia Subjects
NCT02947334
- Beijing, Beijing
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | Efficacy And Safety Of Bococizumab For Lipid Lowering In Asian Hypercholesterolemia Subjects | ||||
| Official Title ICMJE | A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Bococizumab (Pf-04950615) In Asian Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events | ||||
| Brief Summary | This study is a Phase 3, double blind, placebo controlled, randomized, stratified, parallel group, multi-center clinical trial designed to compare the efficacy and safety of bococizumab 150 mg SC Q2wks to placebo for LDL-C lowering in subjects with primary hyperlipidemia or mixed dyslipidemia at high or very high risk for CV events. The study will enroll a total of approximately 750 subjects from 4 - 5 Asian countries/areas (including China mainland); of which approximately 600 subjects will be from sites in China. Subjects will be randomized into a bococizumab treatment arm and a placebo arm in a 1:1 ratio. | ||||
| Detailed Description | After providing consent, subjects will enter a screening period of approximately 28 days to verify eligibility for the trial. Eligible subjects will be considered enrolled and progress to the Randomization visit. Results from screening evaluations will be reviewed and only subjects who continue to meet all eligibility criteria will be randomized. Randomized subjects will enter the 12-week treatment period, followed by a 40-week long-term treatment period and a 6 week follow-up, for a total of 58 weeks (approximately 14 months) study participation. Subjects will attend clinic visits as shown in the Schedule of Activities. Subjects will be randomized to receive either 150 mg Q2wks of bococizumab or placebo in a 1:1 ratio. Lipid levels will be blinded to the investigator and staff, subject and sponsor. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | ||||
| Condition ICMJE | Primary Hyperlipidemia or Mixed Dyslipidemia | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Actual Enrollment ICMJE | 0 | ||||
| Original Estimated Enrollment ICMJE | 750 | ||||
| Estimated Study Completion Date ICMJE | May 3, 2019 | ||||
| Estimated Primary Completion Date | May 3, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender ICMJE |
| ||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT02947334 | ||||
| Other Study ID Numbers ICMJE | B1481047 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement ICMJE |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||
| Verification Date | November 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||