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

Last updated on March 15, 2019

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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.
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- 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.
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- 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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