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Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PBO
200mg PF-04950615 (RN316)
300mg PF-04950615 (RN316)
PBO
PF-04950615
PF-04950615
PF-04950615
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:

  • Subjects should be receiving a stable dose (at least 6 weeks) of any statin and continue on same dose of statin for the duration of this trial.
  • Lipids should meet the following criteria on a background treatment with a statin at 2 screening visits that occur at screening and at least 7 days prior to randomization on Day 1:
  • Fasting LDL-C greater than or equal to 80 mg/dL (2.31 mmol/L);
  • Fasting TG less than or equal to 400 mg/dL (4.52 mmol/L).
  • Subject's fasting LDL-cholesterol must greater than or equal to 80 mg/dL (2.31 mmol/L at the initial screening visit, and the value at the second visit within 7 days of randomization must be not lower than 20% of this initial value to meet eligibility criterion for this trial.

Exclusion Criteria:

  • Participation in other studies within 3 months before the current study begins and/or during study participation.
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 63 days after last dose of investigational product.
  • History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past 6 months. Congestive heart failure (CHF), NYHA functional classes III or IV.
  • Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%).
  • Poorly controlled hypertension.

Sites / Locations

  • Achieve Clinical Research, LLC
  • Medical Affiliated Research Center, Inc.
  • The Office of James G. McMurray, MD
  • Southwest Heart Group
  • Aureus Research Inc.
  • Universal Biopharma Research Institute Inc. - Alta Family Health Clinic
  • Clinical Trials Research
  • The Office of Lucita M. Cruz, MD, Inc.
  • Radiant Research
  • St. Joseph's Medical Associates
  • Orange County Research Center
  • Diablo Clinical Research, Inc.
  • Chase Medical Research, LLC
  • Zasa Clinical Research
  • Florida Health Center
  • Avail Clinical Research, LLC
  • Florida Research Network, LLC
  • In Vivo Clinical Research, Inc.
  • Health Care Family Rehab and Research Center
  • Jacksonville Center for Clinical Research
  • Community Research Foundation, Inc.
  • Kendall South Medical Center, Inc.
  • Omega Research Consultants, LLC
  • DMI Research
  • St Johns Center for Clinical Research
  • The Office of Bridget Bellingar, DO
  • Miami Research Associates
  • Atlanta Center for Medical Research
  • Radiant Research, Inc.
  • North Georgia Clinical Research
  • East-West Medical Research Institute
  • Northwest Clinical Trials
  • Fox Valley Clinical Research Center, LLC
  • Radiant Research, Inc.
  • Midwest Institute for Clinical Research
  • Midwest Heart & Vascular Specialists
  • L-MARC Research Center
  • Crescent City Clinical Research Center
  • Maine Research Associates
  • Maine Research Associates
  • ActivMed Practices and Research
  • Radiant Research, Inc.
  • Dybedal Clinical Research Center
  • Montana Medical Research, Inc.
  • Meridian Clinical Research
  • New Mexico Clinical Research and Osteoporosis Center, Inc.
  • Central New York Clinical Research
  • Clinical Trials of America, Inc.
  • North Carolina Clinical Research
  • PMG Research of Raleigh
  • Wake Internal Medicine Consultants
  • PMG Research of Salisbury
  • Ardmore Family Practice
  • Clinical Trials of America, Inc.
  • Sterling Research Group, Ltd.
  • Sentral Clinical Research Services
  • Sterling Research Group, LTD.
  • Albert J. Weisbrot, M.D., Inc.
  • Lynn Institute of Norman
  • Lynn Health Science Institute
  • Altoona Center for Clinical Research
  • Upstate Pharmaceutical Research
  • Coastal Carolina Research Center
  • Palmetto Clinical Research
  • New Orleans Center for Clinical Research
  • Volunteer Research Group
  • Baylor College of Medicine - Center for Cardiovascular Disease Prevention
  • Texas Center for Drug Development, Inc.
  • Protenium Clinical Research, LLC
  • Paragon Research Center, LLC
  • Innovative Clinical Trials
  • National Clinical Research- Norfolk, Inc
  • National Clinical Research - Richmond, Inc.
  • Premier Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Q28d Dosing Arm

Q14d Dosing Arm

Arm Description

A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q28d dose group will receive subcutaneous administration of PF-04950615 or Placebo once a month.

A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q14d dose group will receive subcutaneous administration of PF-04950615 or Placebo every 2 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12

Secondary Outcome Measures

Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24
Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24
Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24
Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24
Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24
Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24
Change From Baseline in Total Cholesterol at Week 12 and 24
Percent Change From Baseline in Total Cholesterol at Week 12 and 24
Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24
Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24
Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24
Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24
Change From Baseline in Triglycerides at Week 12 and 24
Percent Change From Baseline in Triglycerides at Week 12 and 24
Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24
Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24
Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)
Participants with titer value greater than or equal to 4.32 nanogram per milliliter were considered positive.
Percentage of Participants With Injection Site Adverse Events
Injection site adverse events included injection site bruising, discomfort, erythema, hemorrhage, induration, inflammation, pain, paresthesia, pruritus, swelling, urticaria, reaction and rash.
Plasma Concentration of PF-04950615 at Week 12 and 24
Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)

Full Information

First Posted
May 3, 2012
Last Updated
October 27, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01592240
Brief Title
Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
Official Title
A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel Group, Dose-ranging Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Monthly And Twice Monthly Subcutaneous Dosing For Six Months In Hypercholesterolemic Subjects On A Statin
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is >/=80 mg/dL on background treatment with a statin.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
354 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Q28d Dosing Arm
Arm Type
Experimental
Arm Description
A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q28d dose group will receive subcutaneous administration of PF-04950615 or Placebo once a month.
Arm Title
Q14d Dosing Arm
Arm Type
Experimental
Arm Description
A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q14d dose group will receive subcutaneous administration of PF-04950615 or Placebo every 2 weeks.
Intervention Type
Drug
Intervention Name(s)
PBO
Intervention Description
Placebo Q28d
Intervention Type
Drug
Intervention Name(s)
200mg PF-04950615 (RN316)
Other Intervention Name(s)
PF-04950615 (RN316)
Intervention Description
PF-04950615 200 mg, Q28d
Intervention Type
Drug
Intervention Name(s)
300mg PF-04950615 (RN316)
Other Intervention Name(s)
PF-04950615 (RN316)
Intervention Description
PF-04950615 300 mg, Q28d
Intervention Type
Drug
Intervention Name(s)
PBO
Intervention Description
Placebo, Q14d
Intervention Type
Drug
Intervention Name(s)
PF-04950615
Other Intervention Name(s)
PF-04950615 (RN316)
Intervention Description
PF-04950615 50mg, Q14d
Intervention Type
Drug
Intervention Name(s)
PF-04950615
Other Intervention Name(s)
PF-04950615 (RN316)
Intervention Description
PF-04950615 100 mg, Q14d
Intervention Type
Drug
Intervention Name(s)
PF-04950615
Other Intervention Name(s)
PF-04950615 (RN316)
Intervention Description
PF-04950615 150mg, Q14d
Primary Outcome Measure Information:
Title
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
Time Frame
Baseline, Week 24
Title
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Change From Baseline in Total Cholesterol at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Percent Change From Baseline in Total Cholesterol at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Change From Baseline in Triglycerides at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Percent Change From Baseline in Triglycerides at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24
Time Frame
Baseline, Week 12, 24
Title
Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)
Description
Participants with titer value greater than or equal to 4.32 nanogram per milliliter were considered positive.
Time Frame
Baseline up to Day 211 for every 28 days groups and Baseline up to Day 225 for every 14 days groups
Title
Percentage of Participants With Injection Site Adverse Events
Description
Injection site adverse events included injection site bruising, discomfort, erythema, hemorrhage, induration, inflammation, pain, paresthesia, pruritus, swelling, urticaria, reaction and rash.
Time Frame
Baseline up to Day 211 for 28 days groups and Baseline up to Day 225 for 14 days groups
Title
Plasma Concentration of PF-04950615 at Week 12 and 24
Time Frame
Week 12, 24
Title
Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)
Time Frame
Week 12, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects should be receiving a stable dose (at least 6 weeks) of any statin and continue on same dose of statin for the duration of this trial. Lipids should meet the following criteria on a background treatment with a statin at 2 screening visits that occur at screening and at least 7 days prior to randomization on Day 1: Fasting LDL-C greater than or equal to 80 mg/dL (2.31 mmol/L); Fasting TG less than or equal to 400 mg/dL (4.52 mmol/L). Subject's fasting LDL-cholesterol must greater than or equal to 80 mg/dL (2.31 mmol/L at the initial screening visit, and the value at the second visit within 7 days of randomization must be not lower than 20% of this initial value to meet eligibility criterion for this trial. Exclusion Criteria: Participation in other studies within 3 months before the current study begins and/or during study participation. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 63 days after last dose of investigational product. History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past 6 months. Congestive heart failure (CHF), NYHA functional classes III or IV. Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%). 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
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Medical Affiliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
The Office of James G. McMurray, MD
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Southwest Heart Group
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Aureus Research Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Universal Biopharma Research Institute Inc. - Alta Family Health Clinic
City
Dinuba
State/Province
California
ZIP/Postal Code
93618
Country
United States
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
The Office of Lucita M. Cruz, MD, Inc.
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Radiant Research
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
St. Joseph's Medical Associates
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
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
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Zasa Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Florida Health Center
City
Davie
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Florida Research Network, LLC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
In Vivo Clinical Research, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
Country
United States
Facility Name
Health Care Family Rehab and Research Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Community Research Foundation, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Kendall South Medical Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Omega Research Consultants, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
DMI Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
St Johns Center for Clinical Research
City
Ponte Vedra
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
Facility Name
The Office of Bridget Bellingar, DO
City
Seminole
State/Province
Florida
ZIP/Postal Code
33774
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Radiant Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Northwest Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Fox Valley Clinical Research Center, LLC
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Radiant Research, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Midwest Heart & Vascular Specialists
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Crescent City Clinical Research Center
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Maine Research Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Maine Research Associates
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
ActivMed Practices and Research
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Radiant Research, Inc.
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Dybedal Clinical Research Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64106
Country
United States
Facility Name
Montana Medical Research, Inc.
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
New Mexico Clinical Research and Osteoporosis Center, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Central New York Clinical Research
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
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 Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Wake Internal Medicine Consultants
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Ardmore Family Practice
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Sterling Research Group, Ltd.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Sentral Clinical Research Services
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Sterling Research Group, LTD.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Albert J. Weisbrot, M.D., Inc.
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Lynn Institute of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Upstate Pharmaceutical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Palmetto Clinical Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
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
Baylor College of Medicine - Center for Cardiovascular Disease Prevention
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
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
Protenium Clinical Research, LLC
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Paragon Research Center, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Innovative Clinical Trials
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
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25784512
Citation
Ballantyne CM, Neutel J, Cropp A, Duggan W, Wang EQ, Plowchalk D, Sweeney K, Kaila N, Vincent J, Bays H. Results of bococizumab, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9, from a randomized, placebo-controlled, dose-ranging study in statin-treated subjects with hypercholesterolemia. Am J Cardiol. 2015 May 1;115(9):1212-21. doi: 10.1016/j.amjcard.2015.02.006. Epub 2015 Feb 12.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1481015&StudyName=Monthly%20And%20Twice%20Monthly%20Subcutaneous%20Dosing%20Of%20PF-04950615%20%28RN316%29%20%20In%20Hypercholesterolemic%20Subjects%20On%20A%20Statin
Description
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Learn more about this trial

Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin

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