Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
Status: | Completed |
---|---|
Conditions: | High Cholesterol |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/7/2017 |
Start Date: | July 2012 |
End Date: | May 2013 |
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.
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.
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.
We found this trial at
73
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Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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1300 North Fresno Street
Dinuba, California 93618
Dinuba, California 93618
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1 Baylor Plaza
Houston, Texas 77030
Houston, Texas 77030
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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