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Trial record 1 of 1 for:    NCT01592240
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Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin

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ClinicalTrials.gov Identifier: NCT01592240
Recruitment Status : Completed
First Posted : May 7, 2012
Results First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 3, 2012
First Posted Date  ICMJE May 7, 2012
Results First Submitted Date  ICMJE October 27, 2017
Results First Posted Date  ICMJE December 5, 2017
Last Update Posted Date December 5, 2017
Actual Study Start Date  ICMJE July 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2012)
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 ]
Change History Complete list of historical versions of study NCT01592240 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2012)
  • 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 ]
  • Safety endpoints will include incidence of anti-drug antibody (ADA), injection site [ Time Frame: Month 6 ]
  • Plasma steady-state PF-04950615 pharmacokinetic parameters what PK measurements are being done? [ Time Frame: Month 6 ]
  • Proportion of subjects having LDL-C less than particular limits (<100mg/dL, <70 mg/dL, <40mg/L, <25mg/dL) [ Time Frame: Month 6 ]
  • Total cholesterol will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 ]
  • Apolipoprotein B (ApoB) will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Triglycerides will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 ]
  • non-HDL-cholesterol will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: PBO
    • Drug: 200mg PF-04950615 (RN316)
    • Drug: 300mg 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.
    Interventions:
    • Drug: PBO
    • Drug: PF-04950615
    • Drug: PF-04950615
    • Drug: PF-04950615
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2017)
354
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2012)
350
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01592240
Other Study ID Numbers  ICMJE B1481015
2012-001226-10 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP