A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins
A Phase 2, Double-blind, Placebo-controlled, Randomized Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Multiple Intravenous Doses In Hypercholesterolemic Subjects On Maximum Dose Of Atorvastatin Or Rosuvastatin.
1 other identifier
interventional
46
2 countries
35
Brief Summary
PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2011
Shorter than P25 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2011
CompletedFirst Posted
Study publicly available on registry
May 9, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
November 8, 2017
CompletedNovember 8, 2017
October 1, 2017
10 months
May 3, 2011
October 2, 2017
October 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Baseline, Day 85
Secondary Outcomes (9)
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL)
Day 29, 57, 85
Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)
Day 29, 57, 85
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Baseline, Day 29, 57, 85
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Baseline, Day 29, 57, 85
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Day 1 up to Day 141
- +4 more secondary outcomes
Study Arms (3)
Treatment A
PLACEBO COMPARATORTreatment B
EXPERIMENTALTreatment C
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Body Mass Index (BMI) of 18.5 to 40 kg/m2
- On a stable maximum daily dose of a statin, defined as atorvastatin 80 mg or rosuvastatin 40 mg for a minimum of 45 days prior to Day 1.
- Lipids meet the following criteria twice during screening period:
- Fasting LDL C = or \> 80 mg/dL;
- Fasting TG \< 400 mg/dL.
You may not qualify if:
- History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past year.
- Poorly controlled type 1 or type 2 diabetes mellitus.
- Poorly controlled hypertension.
- Fasting triglycerides \> 400 mg/dL
- lead ECG demonstrating QTcFF \>455 msec at screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (35)
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
Advance Outcome Management, Inc.
Garden Grove, California, 92845, United States
Collaborative Neuroscience Network, Inc
Garden Grove, California, 92845, United States
Collaborative Neuroscience Network, Inc.
Long Beach, California, 90806, United States
Elite Clinical Trials, Inc.
Wildomar, California, 92595, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Kendall South Medical Center, Inc.
Miami, Florida, 33185, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30309, United States
Midwest Cardiology Associates
Overland Park, Kansas, 66209, United States
Stark Pharmacy
Overland Park, Kansas, 66209, United States
Vince and Associates Clinical Research
Overland Park, Kansas, 66212, United States
Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
Saint Luke's Lipid and Diabetes Research Center
Kansas City, Missouri, 64111, United States
Advance Clinical Research
St Louis, Missouri, 63128, United States
Wake Internal Medicine Consultants, Inc.
Raleigh, North Carolina, 27612, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120, United States
Oklahoma Heart Hospital Physicians
Oklahoma City, Oklahoma, 73120, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
DeGarmo Institute of Medical Research
Greer, South Carolina, 29651, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Texas Center for Drug Development, Inc
Houston, Texas, 77081, United States
Martin Diagnostic Clinic
Tomball, Texas, 77375, United States
Aspen Clinical Research, LLC
Orem, Utah, 84058, United States
National Clinical Research - Richmond, Inc.
Richmond, Virginia, 23294, United States
The Medical Arts Health Research Group
Kelowna, British Columbia, V1Y 3G8, Canada
Q & T Research Chicoutimi
Chicoutimi, Quebec, G7H 7Y8, Canada
Centre de Recherche Clinique de Laval
Laval, Quebec, H7T 2P5, Canada
Diex Research Montreal Inc.
Montreal, Quebec, H4N 3C5, Canada
Clinique des Maladies Lipidiques de Quebec Inc.
Québec, Quebec, G1V 4M6, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1H 1Z1, Canada
Related Publications (3)
Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
PMID: 37994400DERIVEDWan H, Gumbiner B, Joh T, Riel T, Udata C, Forgues P, Garzone PD. Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition with Bococizumab on Lipoprotein Particles in Hypercholesterolemic Subjects. Clin Ther. 2017 Nov;39(11):2243-2259.e5. doi: 10.1016/j.clinthera.2017.09.009. Epub 2017 Oct 14.
PMID: 29037448DERIVEDUdata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9.
PMID: 28181260DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to an inadvertent omission in the protocol at Day 85, presented limitations in data collection and the assessment of treatment effect on ApoA1 and ApoB for Day 85.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2011
First Posted
May 9, 2011
Study Start
June 1, 2011
Primary Completion
April 1, 2012
Study Completion
June 1, 2012
Last Updated
November 8, 2017
Results First Posted
November 8, 2017
Record last verified: 2017-10