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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01592240
First Posted: May 7, 2012
Last Update Posted: December 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention Phase
Hypercholesterolemia Drug: PBO Drug: 200mg PF-04950615 (RN316) Drug: 300mg PF-04950615 (RN316) Drug: PF-04950615 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]

Secondary Outcome Measures:
  • Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24 [ Time Frame: Baseline, Week 24 ]
  • Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Change From Baseline in Total Cholesterol at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Percent Change From Baseline in Total Cholesterol at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Change From Baseline in Triglycerides at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Percent Change From Baseline in Triglycerides at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24 [ Time Frame: Baseline, Week 12, 24 ]
  • Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA) [ Time Frame: Baseline up to Day 211 for every 28 days groups and Baseline up to Day 225 for every 14 days groups ]
    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 [ Time Frame: Baseline up to Day 211 for 28 days groups and Baseline up to Day 225 for 14 days groups ]
    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 [ Time Frame: Week 12, 24 ]
  • 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 ]

Enrollment: 354
Actual Study Start Date: July 2012
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Q28d Dosing Arm
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.
Drug: PBO
Placebo Q28d
Drug: 200mg PF-04950615 (RN316)
PF-04950615 200 mg, Q28d
Other Name: PF-04950615 (RN316)
Drug: 300mg PF-04950615 (RN316)
PF-04950615 300 mg, Q28d
Other Name: PF-04950615 (RN316)
Experimental: Q14d Dosing Arm
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.
Drug: PBO
Placebo, Q14d
Drug: PF-04950615
PF-04950615 50mg, Q14d
Other Name: PF-04950615 (RN316)
Drug: PF-04950615
PF-04950615 100 mg, Q14d
Other Name: PF-04950615 (RN316)
Drug: PF-04950615
PF-04950615 150mg, Q14d
Other Name: PF-04950615 (RN316)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592240


  Hide Study Locations
Locations
United States, Alabama
Achieve Clinical Research, LLC
Birmingham, Alabama, United States, 35216
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
The Office of James G. McMurray, MD
Huntsville, Alabama, United States, 35801
United States, Arizona
Southwest Heart Group
Tucson, Arizona, United States, 85710
United States, Arkansas
Aureus Research Inc.
Little Rock, Arkansas, United States, 72205
United States, California
Universal Biopharma Research Institute Inc. - Alta Family Health Clinic
Dinuba, California, United States, 93618
Clinical Trials Research
Lincoln, California, United States, 95648
The Office of Lucita M. Cruz, MD, Inc.
Norwalk, California, United States, 90650
Radiant Research
Santa Rosa, California, United States, 95405
St. Joseph's Medical Associates
Stockton, California, United States, 95204
Orange County Research Center
Tustin, California, United States, 92780
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
United States, Connecticut
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Florida
Zasa Clinical Research
Boynton Beach, Florida, United States, 33472
Florida Health Center
Davie, Florida, United States, 33312
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
Florida Research Network, LLC
Gainesville, Florida, United States, 32605
In Vivo Clinical Research, Inc.
Hialeah, Florida, United States, 33010
Health Care Family Rehab and Research Center
Hialeah, Florida, United States, 33012
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Community Research Foundation, Inc.
Miami, Florida, United States, 33155
Kendall South Medical Center, Inc.
Miami, Florida, United States, 33185
Omega Research Consultants, LLC
Orlando, Florida, United States, 32804
DMI Research
Pinellas Park, Florida, United States, 33782
St Johns Center for Clinical Research
Ponte Vedra, Florida, United States, 32081
The Office of Bridget Bellingar, DO
Seminole, Florida, United States, 33774
Miami Research Associates
South Miami, Florida, United States, 33143
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
Radiant Research, Inc.
Atlanta, Georgia, United States, 30328
North Georgia Clinical Research
Woodstock, Georgia, United States, 30189
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
United States, Idaho
Northwest Clinical Trials
Boise, Idaho, United States, 83704
United States, Illinois
Fox Valley Clinical Research Center, LLC
Aurora, Illinois, United States, 60504
Radiant Research, Inc.
Chicago, Illinois, United States, 60654
United States, Indiana
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States, 46260
United States, Kansas
Midwest Heart & Vascular Specialists
Overland Park, Kansas, United States, 66209
United States, Kentucky
L-MARC Research Center
Louisville, Kentucky, United States, 40213
United States, Louisiana
Crescent City Clinical Research Center
Metairie, Louisiana, United States, 70006
United States, Maine
Maine Research Associates
Auburn, Maine, United States, 04210
Maine Research Associates
Lewiston, Maine, United States, 04240
United States, Massachusetts
ActivMed Practices and Research
Haverhill, Massachusetts, United States, 01830
United States, Minnesota
Radiant Research, Inc.
Edina, Minnesota, United States, 55435
United States, Missouri
Dybedal Clinical Research Center
Kansas City, Missouri, United States, 64106
United States, Montana
Montana Medical Research, Inc.
Missoula, Montana, United States, 59808
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, New Mexico
New Mexico Clinical Research and Osteoporosis Center, Inc.
Albuquerque, New Mexico, United States, 87106
United States, New York
Central New York Clinical Research
Manlius, New York, United States, 13104
United States, North Carolina
Clinical Trials of America, Inc.
Hickory, North Carolina, United States, 28601
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
PMG Research of Raleigh
Raleigh, North Carolina, United States, 27609
Wake Internal Medicine Consultants
Raleigh, North Carolina, United States, 27612
PMG Research of Salisbury
Salisbury, North Carolina, United States, 28144
Ardmore Family Practice
Winston-Salem, North Carolina, United States, 27103
Clinical Trials of America, Inc.
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States, 45219
Sentral Clinical Research Services
Cincinnati, Ohio, United States, 45236
Sterling Research Group, LTD.
Cincinnati, Ohio, United States, 45246
Albert J. Weisbrot, M.D., Inc.
Mason, Ohio, United States, 45040
United States, Oklahoma
Lynn Institute of Norman
Norman, Oklahoma, United States, 73069
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Upstate Pharmaceutical Research
Greenville, South Carolina, United States, 29615
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
Palmetto Clinical Research
Summerville, South Carolina, United States, 29485
United States, Tennessee
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920
Volunteer Research Group
Knoxville, Tennessee, United States, 37920
United States, Texas
Baylor College of Medicine - Center for Cardiovascular Disease Prevention
Houston, Texas, United States, 77030
Texas Center for Drug Development, Inc.
Houston, Texas, United States, 77081
Protenium Clinical Research, LLC
Hurst, Texas, United States, 76054
Paragon Research Center, LLC
San Antonio, Texas, United States, 78205
Innovative Clinical Trials
San Antonio, Texas, United States, 78229
United States, Virginia
National Clinical Research- Norfolk, Inc
Norfolk, Virginia, United States, 23502
National Clinical Research - Richmond, Inc.
Richmond, Virginia, United States, 23294
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01592240     History of Changes
Other Study ID Numbers: B1481015
2012-001226-10 ( EudraCT Number )
First Submitted: May 3, 2012
First Posted: May 7, 2012
Results First Submitted: October 27, 2017
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017
Last Verified: October 2017

Keywords provided by Pfizer:
PF-04950615
RN316

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases