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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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01592240
First received: May 3, 2012
Last updated: October 14, 2014
Last verified: October 2014

May 3, 2012
October 14, 2014
July 2012
May 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01592240 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ] [ 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 ] [ 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 ] [ 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 ] [ 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 ] [ 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 ] [ 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 ] [ 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 ] [ 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia
  • 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)
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
356
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01592240
B1481015
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2014

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