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A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins

Primary Purpose

Hypercholesterolemia, Dyslipidemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Statin
PF-04950615 (RN316)
Statin
PF-04950615 (RN316)
Statin
PF-04950615 (RN316)
Satin
PF-04950615 (RN316)
Statin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring PF-04950615, RN316

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Orange County Research Center
  • Diablo Clinical Research, Inc.
  • Innovative Research of West Florida, Inc.
  • Avail Clinical Research, LLC
  • In Vivo Clinical Research, Inc.
  • Jacksonville Center for Clinical Research
  • Kendall South Medical Center
  • North Georgia Clinical Research
  • North Georgia Internal Medicine
  • Vince and Associates Clinical Research
  • Heartland Research Associates, LLC
  • L-MARC Research Center
  • Commonwealth Biomedical Research, LLC
  • Maine Research Associates
  • Infinity Medical Research
  • Saint Luke's Hospital
  • Saint Luke's Lipid and Diabetes Research Center
  • The Center for Pharmaceutical Research, P.C.
  • Medex Healthcare Research, Inc.
  • New Mexico Clinical Research & Osteoporosis Center, Incorporated
  • North Carolina Clinical Research
  • PMG Research of Salisbury
  • Lynn Health Science Institute
  • Oklahoma Cardiovascular Research Group (OCRG)
  • Oklahoma Heart Hospital Physicians
  • Oklahoma Heart Hospital
  • Altoona Center for Clinical Research
  • Perelman Center for Advanced Medicine
  • Translational Research Center
  • Spartanburg Medical Research
  • New Orleans Center for Clinical Research
  • Volunteer Research Group
  • Texas Center for Drug Development, Inc.
  • Paragon Research Center, LLC
  • Clinical Trials of Texas, Inc.
  • San Antonio Preventive & Diagnostic Medicine, PA
  • National Clinical Research - Norfolk, Inc.
  • National Clinical Research - Richmond, Inc.
  • The Medical Arts Health Research Group
  • Q & T Research Chicoutimi
  • Centre de Recherche Clinique de Laval
  • Diex Research Montreal Inc.
  • Diex Research Sherbrooke Inc.
  • Clinique des Maladies Lipidiques de Quebec Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Treatment A

Treatment B

Treatment C

Treatment D

Treatment E

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL)
Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, SAEs and treatment-related TEAEs were reported.
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Investigator assessed TEAEs as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) or severe (interfered significantly with participant's usual function). TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state.
Number of Participants With Clinically Relevant Laboratory Abnormalities
Hematology (hemoglobin[hgb],hematocrit,red blood cell[RBC]<0.8*lower limit of normal[LLN],mean cell[MC] volume,MC hgb,MC hg concentration <0.9*LLN, greater than[>] 1.1*upper limit of normal[ULN], platelet <0.5*LLN,>1.75*ULN, white blood cell[WBC]<0.6*LLN,>1.5*ULN,neutrophil,lymphocyte <0.8*LLN,>1.2*ULN,eosinophil,basophil,monocyte >1.2*ULN);chemistry(total, direct, indirect bilirubin[BR]>1.5*ULN,aspartate aminotransferase[AT],alanine AT,alkaline phosphatase,gamma-glutyl transferase>3.0*ULN,protein,lactate dehydrogenase <0.8*LLN,>1.2*ULN,creatinine,blood urea nitrogen>1.3*ULN,uric acid >1.2*ULN,potassium,chloride,calcium,bicarbonate<0.9*LLN,>1.1*ULN, sodium<0.95*LLN,>1.05*ULN,glucose[GL]<0.6*LLN,>1.5*ULN,amylase,lipase >1.5*ULN,creatinine kinase>2.0*ULN);urinalysis(pH <4.5,>8,specific gravity<1.003 , >1.030, GL,ketone,protein,hgb,BR,nitrite,leukocyte greater than or equal to [>=]1, RBC, WBC >=20);coagulation(prothrombin[PT],PT international ratio,partial thromboplastin time>1.1*ULN).
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of >=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of >=25 percent (%) for baseline value of >200 millisecond (msec) and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for PR and QRS interval; maximum increase from baseline of >30 to <=60 msec and maximum increase from baseline of >60 msec for QT interval corrected using the Fridericia's formula (QTCF).
Number of Participants With Anti-drug Antibody (ADA)
Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value >=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.

Full Information

First Posted
April 25, 2011
Last Updated
September 11, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01342211
Brief Title
A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (Actual)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Dyslipidemia
Keywords
PF-04950615, RN316

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment A
Arm Type
Placebo Comparator
Arm Title
Treatment B
Arm Type
Experimental
Arm Title
Treatment C
Arm Type
Experimental
Arm Title
Treatment D
Arm Type
Experimental
Arm Title
Treatment E
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Intravenous placebo monthly during treatment phase.
Intervention Type
Drug
Intervention Name(s)
Statin
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
PF-04950615 (RN316)
Intervention Description
Intravenous 10mg/mL based on weight monthly during treatment phase.
Intervention Type
Drug
Intervention Name(s)
Statin
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
PF-04950615 (RN316)
Intervention Description
Intravenous 10mg/mL based on weight monthly during treatment phase.
Intervention Type
Drug
Intervention Name(s)
Statin
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
PF-04950615 (RN316)
Intervention Description
Intravenous 10mg/mL based on weight monthly during treatment phase.
Intervention Type
Drug
Intervention Name(s)
Satin
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
PF-04950615 (RN316)
Intervention Description
Intravenous 10mg/mL based on weight monthly during treatment phase.
Intervention Type
Drug
Intervention Name(s)
Statin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85
Description
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Time Frame
Baseline, Day 85
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL)
Time Frame
Day 29, 57, 85
Title
Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)
Time Frame
Day 29, 57, 85
Title
Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Description
Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Time Frame
Baseline, Day 29, 57, 85
Title
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Description
Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Time Frame
Baseline, Day 29, 57, 85
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, SAEs and treatment-related TEAEs were reported.
Time Frame
Day 1 up to Day 141
Title
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
Description
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Investigator assessed TEAEs as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) or severe (interfered significantly with participant's usual function). TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state.
Time Frame
Day 1 up to Day 141
Title
Number of Participants With Clinically Relevant Laboratory Abnormalities
Description
Hematology (hemoglobin[hgb],hematocrit,red blood cell[RBC]<0.8*lower limit of normal[LLN],mean cell[MC] volume,MC hgb,MC hg concentration <0.9*LLN, greater than[>] 1.1*upper limit of normal[ULN], platelet <0.5*LLN,>1.75*ULN, white blood cell[WBC]<0.6*LLN,>1.5*ULN,neutrophil,lymphocyte <0.8*LLN,>1.2*ULN,eosinophil,basophil,monocyte >1.2*ULN);chemistry(total, direct, indirect bilirubin[BR]>1.5*ULN,aspartate aminotransferase[AT],alanine AT,alkaline phosphatase,gamma-glutyl transferase>3.0*ULN,protein,lactate dehydrogenase <0.8*LLN,>1.2*ULN,creatinine,blood urea nitrogen>1.3*ULN,uric acid >1.2*ULN,potassium,chloride,calcium,bicarbonate<0.9*LLN,>1.1*ULN, sodium<0.95*LLN,>1.05*ULN,glucose[GL]<0.6*LLN,>1.5*ULN,amylase,lipase >1.5*ULN,creatinine kinase>2.0*ULN);urinalysis(pH <4.5,>8,specific gravity<1.003 , >1.030, GL,ketone,protein,hgb,BR,nitrite,leukocyte greater than or equal to [>=]1, RBC, WBC >=20);coagulation(prothrombin[PT],PT international ratio,partial thromboplastin time>1.1*ULN).
Time Frame
Day 1 up to Day 141
Title
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
Description
Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of >=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of >=25 percent (%) for baseline value of >200 millisecond (msec) and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for PR and QRS interval; maximum increase from baseline of >30 to <=60 msec and maximum increase from baseline of >60 msec for QT interval corrected using the Fridericia's formula (QTCF).
Time Frame
Day 1 up to Day 141
Title
Number of Participants With Anti-drug Antibody (ADA)
Description
Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value >=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.
Time Frame
Day 1 up to Day 141
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Description
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Time Frame
Baseline, Day 29, 57, 71, 85, 99, 127, 141
Title
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Description
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Time Frame
Baseline, Day 29, 57, 71, 85, 99, 127, 141

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Innovative Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
In Vivo Clinical Research, Inc.
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Kendall South Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
North Georgia Internal Medicine
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Commonwealth Biomedical Research, LLC
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Maine Research Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Infinity Medical Research
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Saint Luke's Lipid and Diabetes Research Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
The Center for Pharmaceutical Research, P.C.
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Medex Healthcare Research, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
New Mexico Clinical Research & Osteoporosis Center, Incorporated
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
PMG Research of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Oklahoma Cardiovascular Research Group (OCRG)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Oklahoma Heart Hospital Physicians
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Oklahoma Heart Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Translational Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Texas Center for Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Paragon Research Center, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
San Antonio Preventive & Diagnostic Medicine, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
National Clinical Research - Norfolk, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
National Clinical Research - Richmond, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
The Medical Arts Health Research Group
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 3G8
Country
Canada
Facility Name
Q & T Research Chicoutimi
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7Y8
Country
Canada
Facility Name
Centre de Recherche Clinique de Laval
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Diex Research Montreal Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 3C5
Country
Canada
Facility Name
Diex Research Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Clinique des Maladies Lipidiques de Quebec Inc.
City
Quebec
ZIP/Postal Code
G1V 4M6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29037448
Citation
Wan 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.
Results Reference
derived
PubMed Identifier
28181260
Citation
Udata 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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1481005&StudyName=A%20Multiple%20Dose%20Study%20of%20PF-04950615%20%28RN316%29%20in%20Subjects%20on%20High%20Doses%20of%20Statins
Description
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A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins

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