A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High 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 High Doses Of Atorvastatin, Rosuvastatin Or Simvastatin.
1 other identifier
interventional
93
2 countries
44
Brief Summary
This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2011
Shorter than P25 for phase_2
44 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
April 25, 2011
CompletedFirst Posted
Study publicly available on registry
April 27, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
October 11, 2017
CompletedOctober 11, 2017
September 1, 2017
7 months
April 25, 2011
September 8, 2017
September 11, 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 <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
Other Outcomes (2)
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Baseline, Day 29, 57, 71, 85, 99, 127, 141
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Baseline, Day 29, 57, 71, 85, 99, 127, 141
Study Arms (5)
Treatment A
PLACEBO COMPARATORTreatment B
EXPERIMENTALTreatment C
EXPERIMENTALTreatment D
EXPERIMENTALTreatment E
EXPERIMENTALInterventions
Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
Intravenous 10mg/mL based on weight monthly during treatment phase.
Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
Eligibility Criteria
You may qualify if:
- On a stable daily dose of atorvastatin, rosuvastatin or simvastatin.
- Lipids meet the following criteria at screening and prior to dosing: Fasting LDL-C greater than 100 mg/dL and fasting TG less than 400 mg/dL
You may not qualify if:
- History of a cardiovascular or cerebrovascular event or procedure during the past year.
- Poorly controlled type 1 or type 2 diabetes mellitus.
- Poorly controlled hypertension.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (44)
Orange County Research Center
Tustin, California, 92780, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
In Vivo Clinical Research, Inc.
Doral, Florida, 33166, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Kendall South Medical Center
Miami, Florida, 33185, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
North Georgia Internal Medicine
Woodstock, Georgia, 30189, United States
Vince and Associates Clinical Research
Overland Park, Kansas, 66212, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, 42431, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Infinity Medical Research
North Dartmouth, Massachusetts, 02747, 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
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, 64114, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, 63117, United States
New Mexico Clinical Research & Osteoporosis Center, Incorporated
Albuquerque, New Mexico, 87106, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
PMG Research of Salisbury
Salisbury, North Carolina, 28144, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Oklahoma Cardiovascular Research Group (OCRG)
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
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Translational Research Center
Philadelphia, Pennsylvania, 19104, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920, United States
Volunteer Research Group
Knoxville, Tennessee, 37920, United States
Texas Center for Drug Development, Inc.
Houston, Texas, 77081, United States
Paragon Research Center, LLC
San Antonio, Texas, 78205, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
San Antonio Preventive & Diagnostic Medicine, PA
San Antonio, Texas, 78229, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, 23502, 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)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to an inadvertent omission in the protocol at Day 85, presented limitations in the assessment of treatment effect on ApoA1, ApoB and Lp(a) 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
April 25, 2011
First Posted
April 27, 2011
Study Start
July 1, 2011
Primary Completion
February 1, 2012
Study Completion
June 1, 2012
Last Updated
October 11, 2017
Results First Posted
October 11, 2017
Record last verified: 2017-09