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Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin

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NCT01163851

Last updated on March 22, 2018
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FOR MORE INFORMATION
Study Location
Premier Research Group, Limited
Peoria, Arizona, 85381 United States
See other locations
Contact
1-800-718-1021
[email protected]
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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

- On stable doses of atorvastatin (40 mg daily) for 45 days prior to Day 1.

- BMI 18.5 to 40 kg/m2 inclusive, and body weight equal or lower than 150 kg.

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

- History of a cardiovascular event (e.g., MI ) during the past year.

- Poorly controlled Type 1 or Type 2 Diabetes mellitus (definition: uncontrolled
diabetes is defined as HBIAc >9%).

- Poorly controlled hypertension (uncontrolled hypertension is defined as a systolic
blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm
Hg, even with treatment). Subjects who have hypertension and are controlled on stable
dosages of anti-hypertensive medications can be included.

NCT01163851
Pfizer
Completed
Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin

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Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin
A Phase 1 Study Evaluating The Pharmacokinetics And Pharmacodynamics Of Rn316 In Combination With Atorvastatin In Hypercholesterolemic Subjects
The primary objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of a single dose of PF-04950615 (RN316) in volunteers on stable doses of atorvastatin. PF-04950615 (RN316) is an investigational drug that is currently being studies as a cholesterol lowering therapy.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypercholesterolemia
  • Dyslipidemia
  • Biological: 4 mg/kg
    RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.
    Other Name: PF-04950615 (RN316)
  • Biological: 0.5 mg/kg
    RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.
    Other Name: PF-04950615 (RN316)
Experimental: PF-04950615 (RN316)
Interventions:
  • Biological: 4 mg/kg
  • Biological: 0.5 mg/kg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
April 2011
February 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • On stable doses of atorvastatin (40 mg daily) for 45 days prior to Day 1.
  • BMI 18.5 to 40 kg/m2 inclusive, and body weight equal or lower than 150 kg.

Exclusion Criteria:

  • History of a cardiovascular event (e.g., MI ) during the past year.
  • Poorly controlled Type 1 or Type 2 Diabetes mellitus (definition: uncontrolled diabetes is defined as HBIAc >9%).
  • Poorly controlled hypertension (uncontrolled hypertension is defined as a systolic blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm Hg, even with treatment). Subjects who have hypertension and are controlled on stable dosages of anti-hypertensive medications can be included.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01163851
B1481003
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

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