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A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins

Primary Purpose

Hypercholesterolemia, Dyslipidemia

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

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hypercholesterolemia, dyslipidemia, high cholesterol, LDL, antibody, PCSK9, PF-04950615, RN316

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 12 lead ECG demonstrating QTcFF >455 msec at screening.

Sites / Locations

  • Achieve Clinical Research, LLC
  • Advance Outcome Management, Inc.
  • Collaborative Neuroscience Network, Inc
  • Collaborative Neuroscience Network, Inc.
  • Elite Clinical Trials, Inc.
  • Innovative Research of West Florida, Inc.
  • Avail Clinical Research, LLC
  • Kendall South Medical Center, Inc.
  • Compass Research, LLC
  • Atlanta Diabetes Associates
  • Midwest Cardiology Associates
  • Stark Pharmacy
  • Vince and Associates Clinical Research
  • Saint Luke's Hospital
  • Saint Luke's Lipid and Diabetes Research Center
  • Advance Clinical Research
  • Wake Internal Medicine Consultants, Inc.
  • Wake Research Associates, LLC
  • Lynn Health Science Institute
  • Oklahoma Cardiovascular Research Group
  • Oklahoma Heart Hospital Physicians
  • Oklahoma Heart Hospital
  • Altoona Center for Clinical Research
  • DeGarmo Institute of Medical Research
  • Holston Medical Group
  • Texas Center for Drug Development, Inc
  • Martin Diagnostic Clinic
  • Aspen Clinical Research, LLC
  • 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 Type

Placebo Comparator

Experimental

Experimental

Arm Label

Treatment A

Treatment B

Treatment C

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 Less Than 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, TESAEs and treatment-related TEAEs were reported.
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Investigator assessed adverse events as mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) or severe (interferes significantly with participant's usual function). All causality TEAEs were assessed for severity. 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 Significant Laboratory Abnormalities
Criteria for clinically significant laboratory abnormalities were based on investigator's discretion. Total number of participants who met the criteria for any laboratory abnormal findings were reported. Laboratory parameters included: hematology, coagulation, liver function, renal function, electrolytes, hormones, chemistry and urinalysis. Screening was 21 days prior to start of study treatment.
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
Number of participants with clinically significant changes in vital signs and ECG findings were reported. 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 greater than 200 millisecond (msec) or 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 greater than (>) 30 to <=60 msec and maximum increase from baseline of >60 msec for QT interval corrected using the Fridericia's formula (QTCF). Screening was 21 days prior to start of study treatment.
Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA)
Human serum samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 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
May 3, 2011
Last Updated
October 4, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01350141
Brief Title
A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum 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 Maximum Dose Of Atorvastatin Or Rosuvastatin.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
April 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
PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Dyslipidemia
Keywords
Hypercholesterolemia, dyslipidemia, high cholesterol, LDL, antibody, PCSK9, PF-04950615, RN316

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
An infusion lasting approximately 60 minutes
Intervention Type
Drug
Intervention Name(s)
PF-04950615 (RN316)
Intervention Description
An infusion lasting approximately 60 minutes
Intervention Type
Drug
Intervention Name(s)
PF-04950615 (RN316)
Intervention Description
An infusion lasting approximately 60 minutes
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 Less Than 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, TESAEs 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 in participant who received study drug without regard to possibility of causal relationship. Investigator assessed adverse events as mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) or severe (interferes significantly with participant's usual function). All causality TEAEs were assessed for severity. 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 Significant Laboratory Abnormalities
Description
Criteria for clinically significant laboratory abnormalities were based on investigator's discretion. Total number of participants who met the criteria for any laboratory abnormal findings were reported. Laboratory parameters included: hematology, coagulation, liver function, renal function, electrolytes, hormones, chemistry and urinalysis. Screening was 21 days prior to start of study treatment.
Time Frame
Screening up to Day 141
Title
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
Description
Number of participants with clinically significant changes in vital signs and ECG findings were reported. 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 greater than 200 millisecond (msec) or 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 greater than (>) 30 to <=60 msec and maximum increase from baseline of >60 msec for QT interval corrected using the Fridericia's formula (QTCF). Screening was 21 days prior to start of study treatment.
Time Frame
Screening up to Day 141
Title
Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA)
Description
Human serum samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 12 lead ECG demonstrating QTcFF >455 msec at screening.
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
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Advance Outcome Management, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Elite Clinical Trials, Inc.
City
Wildomar
State/Province
California
ZIP/Postal Code
92595
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
Kendall South Medical Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Midwest Cardiology Associates
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Stark Pharmacy
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
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
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
Advance Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Wake Internal Medicine Consultants, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
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
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
DeGarmo Institute of Medical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
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
Martin Diagnostic Clinic
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Aspen Clinical Research, LLC
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
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=B1481012&StudyName=A%20Multiple%20Dose%20Study%20Of%20PF-04950615%20%28RN316%29%20In%20Subjects%20On%20Maximum%20Doses%20Of%20Statins
Description
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A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins

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