A 52 Week Study To Assess The Use Of RN316 (PF-04950615) In Subjects With Heterozygous Familial Hypercholesterolemia (SPIRE-FH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01968980
First received: October 21, 2013
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of RN316 (PF-04950615) to lower LDL-C.


Condition Intervention Phase
Heterozygous Familial Hypercholesterolemia
Drug: PF-04950615
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 52 Week, Phase 3 Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Heterozygous Familial Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percent Change from Baseline in LDL-C at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Low Density Lipoprotein (LDL) cholesterol blood concentrations


Secondary Outcome Measures:
  • Change from Baseline in Lipid Parameters at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Mean Total Cholesterol (TC), Apolipoprotein B (ApoB), non- HDL-C, lipoprotein (a), High Density Lipoprotein (HDL), Apolipoprotein A-I (ApoA-I), Apoliprotein A-II (ApoA-II), Very Low Density Lipoprotein (VLDL), Triglycerides, TC/HDL and ApoB/ApoA-I ratio.

  • Change from Baseline in Lipid Parameters at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Low Density Lipoprotein (LDL), Mean Total Cholesterol (TC), Apolipoprotein B (ApoB), non- HDL-C, lipoprotein (a), High Density Lipoprotein (HDL), Apolipoprotein A-I (ApoA-I), Apoliprotein A-II (ApoA-II), Very Low Density Lipoprotein (VLDL), Triglycerides, TC/HDL and ApoB/ApoA-I ratio.

  • Change from Baseline in Lipid Parameters at Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Low Density Lipoprotein (LDL), Mean Total Cholesterol (TC), Apolipoprotein B (ApoB), non- HDL-C, lipoprotein (a), High Density Lipoprotein (HDL), Apolipoprotein A-I (ApoA-I), Apoliprotein A-II (ApoA-II), Very Low Density Lipoprotein (VLDL), Triglycerides, TC/HDL and ApoB/ApoA-I ratio.

  • Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL

  • Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL

  • Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Proportion of Subjects Achieving Fasting LDLC <= 100 mg/dL and <=70 mg/dL

  • Plasma PF-04950615 concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Plasma PF-04950615 concentration

  • Plasma PF-04950615 concentration [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Plasma PF-04950615 concentration

  • Plasma PF-04950615 concentration [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Plasma PF-04950615 concentration


Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04950615 Drug: PF-04950615
150 mg every 2 weeks, subcutaneous injection, 12 months
Other Name: RN316
Placebo Comparator: Placebo Other: Placebo
subcutaneous injection every 2 weeks for 12 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treated with a statin.
  • Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL.
  • High or very high risk of incurring a cardiovascular event.

Exclusion Criteria:

  • Pregnant or breastfeeding females.
  • Cardiovascular or cerebrovascular event of procedures during the past 30 days.
  • Congestive heart failure NYHA class IV.
  • 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: NCT01968980

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 75 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01968980     History of Changes
Other Study ID Numbers: B1481021
Study First Received: October 21, 2013
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
High Risk of cardiovascular events
Heterozygous familial hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias

ClinicalTrials.gov processed this record on September 14, 2014