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NCT02947334 Clinical Trial

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

Primary Hyperlipidemia or Mixed Dyslipidemia Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02947334
Other study ID # B1481047
Secondary ID
Status Withdrawn
Phase Phase 3
First received October 26, 2016
Last updated November 29, 2017
Start date October 31, 2016
Est. completion date May 3, 2019

Study information
Verified date November 2017
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 3, 2019
Est. primary completion date May 3, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Bococizumab
Bococizumab PFS
Drug:
• Placebo
Placebo

Locations
Country Name City State
China Beijing Anzhen Hospital, Capital Medical University Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary • Percent change from baseline in fasting LDL-C 12weeks

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