Phase II ALNPCSSC placebo-controlled, double-blind, cardiology trial
Research type
Research Study
Full title
A placebo-controlled, double-blind, randomized trial to compare the effect of different doses of ALN-PCSSC given as single or multiple subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C.
IRAS ID
192553
Contact name
Danielle Curcio
Contact email
Sponsor organisation
The Medicines Company
Eudract number
2015-003772-74
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This is a clinical research trial involving an investigational drug referred as ALN-PCSSC. ALN-PCSSC is a form of RNA (ribonucleic acid) that blocks the production of a protein called PCSK9. This protein is responsible for controlling the LDL-C levels in the blood. LDL-C is also known as “bad cholesterol” as it is the type of cholesterol that causes a disease of blood vessels called atherosclerosis. Atherosclerosis is caused when too much cholesterol causes plaque to build up on the walls of the arteries (and veins) and the plaque can narrow or clog the arteries. Disease in blood vessels that supply the heart can cause heart attacks. In the brain it can cause strokes. Lowering cholesterol with lifestyle modifications (eg, quitting smoking and improving diet) or with medications (eg, statins) has been shown to decrease the occurrence of strokes and heart attacks. However, as not all patients can be treated adequately, even with the currently available medications, there is a need for new drugs.
This medication is planned for use in patients with atherosclerotic heart disease, or people at risk for getting this disease because they have a family history of the disease or another disease such as diabetes.This phase II placebo-controlled, double-blind, randomized trial is designed to evaluate the effect of different doses of ALN-PCSSC treatment on subjects with high cardiovascular risk and to evaluate the efficacy, safety, and tolerability of ALN-PCSSC injection(s). Results of this study will be used to select a dose(s) for future studies.
REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/1952
Date of REC Opinion
16 Dec 2015
REC opinion
Further Information Favourable Opinion