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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT01592240

Run by

Pfizer

People needed

354

Starts

2012-07-01

Expected to finish

2013-05-01

Last updated by the study team

2017-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Medical Affiliated Research Center, Inc. — Huntsville, Alabama, United States
• The Office of James G. McMurray, MD — Huntsville, Alabama, United States
• Southwest Heart Group — Tucson, Arizona, United States
• Aureus Research Inc. — Little Rock, Arkansas, United States
• Universal Biopharma Research Institute Inc. - Alta Family Health Clinic — Dinuba, California, United States
• Clinical Trials Research — Lincoln, California, United States
• The Office of Lucita M. Cruz, MD, Inc. — Norwalk, California, United States
• Radiant Research — Santa Rosa, California, United States
• St. Joseph's Medical Associates — Stockton, California, United States
• Orange County Research Center — Tustin, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Zasa Clinical Research — Boynton Beach, Florida, United States
• Florida Health Center — Davie, Florida, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Florida Research Network, LLC — Gainesville, Florida, United States
• In Vivo Clinical Research, Inc. — Hialeah, Florida, United States
• Health Care Family Rehab and Research Center — Hialeah, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Community Research Foundation, Inc. — Miami, Florida, United States
• Kendall South Medical Center, Inc. — Miami, Florida, United States
• Omega Research Consultants, LLC — Orlando, Florida, United States
• DMI Research — Pinellas Park, Florida, United States
• St Johns Center for Clinical Research — Ponte Vedra, Florida, United States
• Achieve Clinical Research, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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