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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01592240
First received: May 3, 2012
Last updated: June 24, 2013
Last verified: June 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 (RN316) 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:
  • The absolute change from baseline in Low Density Lipoprotein-cholesterol at the end of week 12 following randomization [ Time Frame: end of week 12 post randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Low Density Lipoprotein-Cholesterol (LDL-C) will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]
  • Safety endpoints will include incidence of anti-drug antibody (ADA), injection site [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
  • Plasma steady-state PF-04950615 pharmacokinetic parameters what PK measurements are being done? [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Proportion of subjects having LDL-C less than particular limits (<100mg/dL, <70 mg/dL, <40mg/L, <25mg/dL) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Total cholesterol will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]
  • Apolipoprotein B (ApoB) will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]
  • Apolipoprotein A1 (ApoA1), Apolipoprotein AII (ApoAII) will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]
  • Lipoprotein (a) (Lp(a)) will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]
  • High Density Lipoprotein (HDL)-cholesterol will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]
  • Very Low Density Lipoprotein (VLDL)-cholesterol will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]
  • Triglycerides will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]
  • non-HDL-cholesterol will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]

Enrollment: 356
Study Start Date: July 2012
Study Completion Date: May 2013
Primary Completion Date: May 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592240

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Locations
United States, Alabama
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Birmingham, Alabama, United States, 35216
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Huntsville, Alabama, United States, 35801
United States, Arizona
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Tucson, Arizona, United States, 85710
United States, Arkansas
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Little Rock, Arkansas, United States, 72211
United States, California
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Dinuba, California, United States, 93618
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Lincoln, California, United States, 95648
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Norwalk, California, United States, 90650
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Santa Rosa, California, United States, 95405
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Stockton, California, United States, 95202
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Stockton, California, United States, 95204
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Tustin, California, United States, 92780
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Walnut Creek, California, United States, 94598
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Waterbury, Connecticut, United States, 06708
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Boynton Beach, Florida, United States, 33472
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Doral, Florida, United States, 33166
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Gainesville, Florida, United States, 32605
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Hialeah, Florida, United States, 33012
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Jacksonville, Florida, United States, 32216
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Miami, Florida, United States, 33185
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Miami, Florida, United States, 33155
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Miami, Florida, United States, 33144
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Orlando, Florida, United States, 32804
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Honolulu, Hawaii, United States, 96814
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Overland Park, Kansas, United States, 66209
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Louisville, Kentucky, United States, 40213
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Metairie, Louisiana, United States, 70006
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Auburn, Maine, United States, 04210
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Haverhill, Massachusetts, United States, 01830
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Edina, Minnesota, United States, 55435
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Kansas City, Missouri, United States, 64106
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Missoula, Montana, United States, 59808
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Omaha, Nebraska, United States, 68134
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Albuquerque, New Mexico, United States, 87106
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Manlius, New York, United States, 13104
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Hickory, North Carolina, United States, 28601
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Raleigh, North Carolina, United States, 27607
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Raleigh, North Carolina, United States, 27612
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Winston-Salem, North Carolina, United States, 27103
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Cincinnati, Ohio, United States, 45224
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Cincinnati, Ohio, United States, 45246
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Mason, Ohio, United States, 45040
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Norman, Oklahoma, United States, 73069
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Oklahoma City, Oklahoma, United States, 73112
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Duncansville, Pennsylvania, United States, 16635
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Greenville, South Carolina, United States, 29615
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Greer, South Carolina, United States, 29650
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Mount Pleasant, South Carolina, United States, 29464
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North Charleston, South Carolina, United States, 29406
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Summerville, South Carolina, United States, 29485
United States, Tennessee
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Knoxville, Tennessee, United States, 37920
United States, Texas
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77081
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Hurst, Texas, United States, 76054
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San Antonio, Texas, United States, 78205
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San Antonio, Texas, United States, 78229
United States, Virginia
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Norfolk, Virginia, United States, 23502
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Richmond, Virginia, United States, 23294
United States, Washington
Pfizer Investigational Site
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01592240     History of Changes
Other Study ID Numbers: B1481015
Study First Received: May 3, 2012
Last Updated: June 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
PF-04950615
RN316

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

ClinicalTrials.gov processed this record on August 25, 2014