Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia

Back to Search
Print
Bookmark Trial

NCT01163838

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Hypercholesterolemia, DyslipidemiaA Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins NCT01350141
  1. Birmingham, Alabama
  2. Garden Grove, California
  3. Garden Grove, California
  4. Long Beach, California
  5. Wildomar, California
  6. Clearwater, Florida
  7. DeLand, Florida
  8. Miami, Florida
  9. Orlando, Florida
  10. Atlanta, Georgia
  11. Overland Park, Kansas
  12. Overland Park, Kansas
  13. Overland Park, Kansas
  14. Kansas City, Missouri
  15. Kansas City, Missouri
  16. Saint Louis, Missouri
  17. Raleigh, North Carolina
  18. Raleigh, North Carolina
  19. Oklahoma City, Oklahoma
  20. Oklahoma City, Oklahoma
  21. Oklahoma City, Oklahoma
  22. Oklahoma City, Oklahoma
  23. Duncansville, Pennsylvania
  24. Greer, South Carolina
  25. Kingsport, Tennessee
  26. Houston, Texas
  27. Tomball, Texas
  28. Orem, Utah
  29. Richmond, Virginia
  30. Kelowna, British Columbia
  31. Chicoutimi, Quebec
  32. Laval, Quebec
  33. Montreal, Quebec
  34. Sherbrooke, Quebec
  35. Quebec,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Hypercholesterolemia, DyslipidemiaA Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins NCT01342211
  1. Tustin, California
  2. Walnut Creek, California
  3. Clearwater, Florida
  4. DeLand, Florida
  5. Doral, Florida
  6. Jacksonville, Florida
  7. Miami, Florida
  8. Woodstock, Georgia
  9. Woodstock, Georgia
  10. Overland Park, Kansas
  11. Wichita, Kansas
  12. Louisville, Kentucky
  13. Madisonville, Kentucky
  14. Auburn, Maine
  15. North Dartmouth, Massachusetts
  16. Kansas City, Missouri
  17. Kansas City, Missouri
  18. Kansas City, Missouri
  19. Saint Louis, Missouri
  20. Albuquerque, New Mexico
  21. Raleigh, North Carolina
  22. Salisbury, North Carolina
  23. Oklahoma City, Oklahoma
  24. Oklahoma City, Oklahoma
  25. Oklahoma City, Oklahoma
  26. Oklahoma City, Oklahoma
  27. Duncansville, Pennsylvania
  28. Philadelphia, Pennsylvania
  29. Philadelphia, Pennsylvania
  30. Spartanburg, South Carolina
  31. Knoxville, Tennessee
  32. Knoxville, Tennessee
  33. Houston, Texas
  34. San Antonio, Texas
  35. San Antonio, Texas
  36. San Antonio, Texas
  37. Norfolk, Virginia
  38. Richmond, Virginia
  39. Kelowna, British Columbia
  40. Chicoutimi, Quebec
  41. Laval, Quebec
  42. Montreal, Quebec
  43. Sherbrooke, Quebec
  44. Quebec,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Hypercholesterolemia, DyslipidemiaPharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin NCT01163851
  1. Peoria, Arizona
  2. Phoenix, Arizona
  3. Phoenix, Arizona
  4. Overland Park, Kansas
  5. Overland Park, Kansas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Hypercholesterolemia, DyslipidemiaMultiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia NCT01163838
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypercholesterolemia
  • Dyslipidemia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 21, 2015)		0
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2010)		91
Estimated Study Completion Date  ICMJE March 2011
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01163838
Other Study ID Numbers  ICMJE B1481002
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 CenterPfizer
PRS Account Pfizer
Verification Date April 2015

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