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

Last updated on March 25, 2018

FOR MORE INFORMATION
Study Location
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01592240
Pfizer
Completed
Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin

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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 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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
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.
 
Completed
354
May 2013
April 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01592240
B1481015
2012-001226-10 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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