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

NCT ID: NCT02947334

Last Updated: 2017-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-05-03

Brief Summary

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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

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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.

Conditions

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Primary Hyperlipidemia or Mixed Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Bococizumab

Bococizumab Q2wks

Group Type EXPERIMENTAL

Bococizumab

Intervention Type BIOLOGICAL

Bococizumab PFS

Placebo

Bococizumab placebo Q2wks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Bococizumab

Bococizumab PFS

Intervention Type BIOLOGICAL

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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RN316

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1481047&StudyName=A%20Phase%203%20Double-blind%2C%20Randomized%2C%20Placebo-controlled%2C%20Parallel-group%20Study%20To%20Assess%20The%20Efficacy%2C%20Safety%20And%20Tolerability%20Of%20Bococizumab%20%28pf-04950615%29%20In%20Asian%20Subjects%20With%20Primary%20Hyperlipidemia%20Or%20Mixed%20Dyslipidemia%20At%20Risk%20Of%20Cardiovascular%20Events

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

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1481047&StudyName=A+Phase+3+Double-blind%2C+Randomized%2C+Placebo-controlled%2C+Parallel-group+Study+To+Assess+The+Efficacy%2C+Safety+And+Tolerability+Of+Bococizumab+%28pf-04950615%29+In+Asian+Subjects+With+Primary+Hyperlipidemia+Or+Mixed+Dyslipidemia+At+Risk+Of+Cardiovascular+Events

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

Other Identifiers

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B1481047

Identifier Type: -

Identifier Source: org_study_id