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Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia, Dyslipidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- LDL-C must be greater or equal to 130 mg/dl

- BMI must be between 18.5 and 40 kg/m2

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

- History of cardiovascular or cerebrovascular event during the past year.

- Poorly controlled type 1 or type 2 diabetes mellitus

- Subjects who have taken lipid lowering therapies within the last 3 months of
screening.

NCT01163838
Pfizer
Withdrawn
Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia

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Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia
A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Multiple Intravenous Doses Of RN316 In Healthy Adult Subjects With Hypercholesterolemia
The primary objective of this study is to evaluate the safety and tolerability of repeated doses of RN316 in eligible healthy volunteers. RN316 is an investigational drug that is currently being studied as a cholesterol lowering therapy.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Hypercholesterolemia
  • Dyslipidemia
  • Biological: Placebo
    Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
  • Biological: 1 mg/kg every 2 weeks
    Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
  • Biological: 2 mg/kg every 4 weeks
    Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
  • Biological: 4 mg/kg every 4 weeks
    Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
  • Biological: 4 mg/kg every 8 weeks
    Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
  • Biological: 8 mg/kg every 8 weeks
    Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
  • Biological: 12 mg/kg every 8 weeks
    Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
  • Experimental: RN316: 1 mg/kg every 2 weeks
    Intervention: Biological: 1 mg/kg every 2 weeks
  • Experimental: RN316: 2 mg/kg every 4 weeks
    Intervention: Biological: 2 mg/kg every 4 weeks
  • Experimental: RN316: 4 mg/kg every 4 weeks
    Intervention: Biological: 4 mg/kg every 4 weeks
  • Experimental: RN316: 4 mg/kg every 8 weeks
    Intervention: Biological: 4 mg/kg every 8 weeks
  • Experimental: RN316: 8 mg/kg every 8 weeks
    Intervention: Biological: 8 mg/kg every 8 weeks
  • Experimental: RN316: 12 mg/kg every 8 weeks
    Intervention: Biological: 12 mg/kg every 8 weeks
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • LDL-C must be greater or equal to 130 mg/dl
  • BMI must be between 18.5 and 40 kg/m2

Exclusion Criteria:

  • History of cardiovascular or cerebrovascular event during the past year.
  • Poorly controlled type 1 or type 2 diabetes mellitus
  • Subjects who have taken lipid lowering therapies within the last 3 months of screening.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01163838
B1481002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2015

ICMJE     Data element required by the

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

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