B1481015 - Pfizer

• Research type

  Research Study

• Full title

  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

• IRAS ID

  106727

• Contact name

  Anthony Wierzbicki

• Sponsor organisation

  Pfizer Inc., 235 East 42nd Street, New York, NY 10017

• Eudract number

  2012-001226-10

• Research summary

  The purpose of this research study is to compare the effects of the study drug, PF-04950615 (RN316) and a placebo to find out which is better for treating high blood cholesterol levels. A placebo looks like the study drug but does not contain any drug. Researchers use a placebo to see if the study drug works better or is safer than not taking anything. PF-04950615 (RN316) is a new investigational drug. A new investigational drug is one that is currently not approved for sale in this country. PF-04950615 (RN316) may work to lower high blood cholesterol levels when given in combination with a statin medication by targeting a specific protein: PCSK9. There will be about 350 people enrolled in this study. The study is being done at about 150 different research sites in 3 countries. About 2 or more people will be enrolled at each site in the UK. This study will use competitive enrollment. This means that when a certain number oparticipants have entered the treatment phase of the study from all of the research sites combined, no more participants will be enrolled at any site. Each participant will be in this study for about 24 weeks. In one group of participants, PF-04950615 (RN316) will be administered monthly (every 4 weeks or 28 days) and the participant will need to visit the study site up to 21 times. In the other group, PF-04950615 (RN316) will be administered twice a month (every 14 days) and the participant will need to visit the study site up to 33 times.

• REC name

  HSC REC A

• REC reference

  12/NI/0119

• Date of REC Opinion

  10 Aug 2012

• REC opinion

  Further Information Favourable Opinion