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Efficacy And Safety Of Bococizumab For Lipid Lowering In Asian Hypercholesterolemia Subjects (SPIRE-ASIA)

Primary Purpose

Primary Hyperlipidemia or Mixed Dyslipidemia

Status

Withdrawn

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Bococizumab

Placebo

About this trial

This is an interventional treatment trial for Primary Hyperlipidemia or Mixed Dyslipidemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beijing Anzhen Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bococizumab

Placebo

Arm Description

Bococizumab Q2wks

Bococizumab placebo Q2wks

Outcomes

Primary Outcome Measures

• Percent change from baseline in fasting LDL-C

Secondary Outcome Measures

Full Information

NCT ID

NCT02947334

First Posted

October 26, 2016

Last Updated

November 29, 2017

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02947334

Brief Title

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

Acronym

SPIRE-ASIA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Withdrawn

Study Start Date

October 31, 2016 (Anticipated)

Primary Completion Date

May 3, 2019 (Anticipated)

Study Completion Date

May 3, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Hyperlipidemia or Mixed Dyslipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bococizumab

Arm Type

Experimental

Arm Description

Bococizumab Q2wks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Bococizumab placebo Q2wks

Intervention Type

Biological

Intervention Name(s)

Bococizumab

Other Intervention Name(s)

RN316

Intervention Description

Bococizumab PFS

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

• Percent change from baseline in fasting LDL-C

Time Frame

12weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Beijing Anzhen Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100029

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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/data_requests

Links:

URL

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

Description

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

URL

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

Description

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

Learn more about this trial

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

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