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

NCT02947334 | Withdrawn Phase 3 DMC

• 1 other identifier: B1481047
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Hyperlipidemia or Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• • Percent change from baseline in fasting LDL-C

  12weeks

Study Arms (2)

Bococizumab

EXPERIMENTAL

Bococizumab Q2wks

Biological: Bococizumab

Placebo

PLACEBO COMPARATOR

Bococizumab placebo Q2wks

Drug: Placebo

Interventions

Bococizumab BIOLOGICAL

Bococizumab PFS

Also known as: RN316

Bococizumab

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

Related Links

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

bococizumab

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: October 27, 2016
• Study Start: October 31, 2016
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: December 2, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)