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Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins (SPIRE-SI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02135029
First received: May 7, 2014
Last updated: March 7, 2017
Last verified: March 2017
  Purpose
This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.

Condition Intervention Phase
Hyperlipidemia Drug: Bococizumab (PF-04950615;RN316) Drug: Atorvastatin Other: Placebo for Bococizumab (PF-04950615;RN316) Other: Placebo for atorvastatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage change from baseline in fasting LDL-C at week 12 [ Time Frame: Baseline, Week 12 ]
    Fasting Low Density Lipoprotein Cholesterol (LDL-C)


Secondary Outcome Measures:
  • Change from Baseline in Lipid Parameters at Week 12 [ Time Frame: Baseline, Week 12 ]
    Percent change in fasting Total Cholesterol (TC), Apolipoprotein B (Apo B), non HDL-C, Lipoprotein (a) (Lp(a), High Density Lipoprotein (HDL), Triglyceride, ApoA-I, and ApoA-II blood concentrations.

  • Change from Baseline in Lipid Parameters at Week 24 [ Time Frame: Baseline, Week 24 ]
    Percent change in fasting Total Cholesterol (TC), LDL-C, Apolipoprotein B (Apo B), non HDL-C, Lipoprotein (a) (Lp(a), High Density Lipoprotein (HDL), Triglyceride, ApoA-I, and ApoA-II blood concentrations.

  • Change from Baseline in Lipid Parameters at Week 12 [ Time Frame: Baseline, Week 12 ]
    Absolute change in fasting LDL-C, TC, HDL-C, non-HDL-C, TG, ApoB, and Lp(a)

  • Proportion of subjects achieving fasting LDL-C less or equal than 100mg/dL at week 12 [ Time Frame: Week 12 ]
    Proportion of subjects achieving fasting LDL-C less or equal than 100mg/dL

  • Proportion of subjects achieving fasting LDL-C less or equal than 100mg/dL at week 24 [ Time Frame: Week 24 ]
    Proportion of subjects achieving fasting LDL-C less or equal than 100mg/dL

  • Proportion of subjects achieving fasting LDL-C less or equal than 70mg/dL at week 12 [ Time Frame: Week 12 ]
    Proportion of subjects achieving fasting LDL-C less or equal than 70mg/dL

  • Proportion of subjects achieving fasting LDL-C less or equal than 70mg/dL at week 24 [ Time Frame: Week 24 ]
    Proportion of subjects achieving fasting LDL-C less or equal than 70mg/dL

  • Plasma PF-04950615 concentration at week 12 [ Time Frame: Week 12 ]
    Plasma PF-04950615 concentration

  • Plasma PF-04950615 concentration at week 24 [ Time Frame: Week 24 ]
    Plasma PF-04950615 concentration

  • Antidrug antibodies [ Time Frame: Week 24 ]
    incidence and titer of anti-drug and neutralizing antibodies

  • Proportion of subjects discontinuing treatment due to musculoskeletal adverse events [ Time Frame: Week 24 ]
    Proportion of subjects discontinuing treatment due to musculoskeletal adverse events


Enrollment: 184
Study Start Date: June 2014
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bococizumab (PF-04950615;RN316)
Bococizumab (PF-04950615;RN316)
Drug: Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks by subcutaneous injection for 24 weeks
Active Comparator: Atorvastatin Drug: Atorvastatin
Atorvastatin PO QD
Placebo Comparator: Placebo Other: Placebo for Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks by subcutaneous injection for 24 weeks
Other: Placebo for atorvastatin
PO QD

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hyperlipidemia
  • Statin Intolerant
  • Fasting LDL-C > = 70 mg/dL Fasting TG < = 400 mg/dL

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • Cardiovascular or cerebrovascular event or procedure within 90 days
  • Severe or life-threatening adverse events with past use of statins
  • Poorly controlled hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02135029

  Show 42 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02135029     History of Changes
Other Study ID Numbers: B1481030
STATIN INTOLERANT
SPIRE-SI ( Other Identifier: Alias Study Number )
Study First Received: May 7, 2014
Last Updated: March 7, 2017

Keywords provided by Pfizer:
Hyperlipidemia
statin intolerance

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 23, 2017