A Phase 3, Double-blind, Double-dummy, Randomized, Placebo And Active Controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of PF-04950615 In Subjects With Dyslipidemia Who Are Intolerant To Statins.
Phase of Trial: Phase III
Latest Information Update: 17 Mar 2017
At a glance
- Drugs Bococizumab (Primary) ; Atorvastatin
- Indications Dyslipidaemias; Hyperlipidaemia
- Focus Registrational; Therapeutic Use
- Acronyms SPIRE-SI
- Sponsors Pfizer
- 17 Mar 2017 Results of a pooled analysis from SPIRE-HR, SPIRE-LDL, SPIRE-LDL, SPIRE-LL, SPIRE-SI and SPIRE-AI studies (n=4449), published in the New England Journal of Medicine.
- 01 Jan 2016 According to a Pfizer media release, the results from other phase III studies evaluating LDL-C reduction are expected throughout 2016. Complete study results of the SPIRE-SI will be presented at an upcoming scientific congress.
- 01 Jan 2016 According to a Pfizer media release, primary endpoint (Percentage change from baseline in fasting LDL-C at week 12) has been met.