Effect of Tredaptive on serum lipoproteins and inflammatory markers
Research type
Research Study
Full title
Effect of Tredaptive on serum lipoproteins, lipoproteins metabolism, oxidative stress and HDL antioxidant function.
IRAS ID
37913
Contact name
Handrean Soran
Sponsor organisation
Manchester Royal Infirmary
Eudract number
2010-018531-17
Clinicaltrials.gov Identifier
Research summary
Effect of Tredaptive on serum lipoproteins, lipoproteins metabolism, oxidative stress and HDL antioxidant function. Cardiovascular disease (CVD) is associated with high levels of low-density lipoprotein (LDL) cholesterol and low levels of high-density lipoprotein (HDL) cholesterol. CVD results from ??hardening of the arteries?? when there is a build-up of cholesterol in the walls of blood vessels. LDL is the main carrier of cholesterol in the body. LDL particles are responsible for transporting cholesterol that is deposited in vessel walls. LDL particles can also be altered in structure and turn into an irritant to the vessel walls. The body responds to the irritating effect of LDL by producing substances that result in inflammation. This sequence of events eventually leads to the vessels becoming permanently damaged. HDL has a protective role in CVD. It is associated with the enzyme paraoxonase which protects the body from the damaging effects of altered LDL particles. Nicotinic acid (niacin) has the ability to lower LDL levels and raise HDL levels thus reducing the incidence of CVD. Our study aims to show that niacin not only has good effects on cholesterol levels but is also able to reduce inflammation. Niacin is often poorly tolerated due tfluhing side effect. Tredaptive is a formulation that combines niacin with laropiprant, an agent that reducefluhing hence improving tolerability and compliance. Patients who are receiving cholesterol-lowering medication and whose LDL levels have not reached the recommended target are recruited to the study. The study will be conducted at the Manchester Royal Infirmary. The study has two consecutive 16 week periods. In each period patients will be randomised to either tredaptive or placebo. They will attend for 5 monitoring visits. Apart from the first visit, fasting blood samples will be taken from them during all subsequent visits.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
10/H1008/41
Date of REC Opinion
25 Jun 2010
REC opinion
Further Information Favourable Opinion