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Efficacy And Safety Of Bococizumab For Lipid Lowering In Asian Hypercholesterolemia Subjects

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NCT02947334

Last updated on April 6, 2020
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Study Location
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing, 100029 China
See other locations
Contact
1-800-718-1021
[email protected]
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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
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

- 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.

NCT02947334
Pfizer
Withdrawn
Efficacy And Safety Of Bococizumab For Lipid Lowering In Asian Hypercholesterolemia Subjects

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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
  • Biological: Bococizumab
    Bococizumab PFS
    Other Name: RN316
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Bococizumab
    Bococizumab Q2wks
    Intervention: Biological: Bococizumab
  • Placebo Comparator: Placebo
    Bococizumab placebo Q2wks
    Intervention: Drug: Placebo
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
 (submitted: December 5, 2016) 		0
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2016) 		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:

  • 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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
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

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