Hypercholesterolaemia.
Conditions
Interventions
Trade Name: Tredaptive
Product Name: Tredaptive
Pharmaceutical Form: Tablet
INN or Proposed INN: nicotinic acid
Concentration unit: GBq/g gigabecquerel/gram
Concentration type: range
Concentration num
Sponsors
Central Manchester University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women who are taking cholesterol-lowering medication (maximum tolerated statins and/or ezetimibe) and who have not reached the recommended LDL target of less than 1.8 mmol/l (70 mg/l). Ezetimibe will be stopped 4 weeks before entering the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant and/or breast-feeding women. Significant renal impairment (eGFR 3 times upper limit of normal range. Patients on fibrates. Patients on Omacor. Patients who are allergic to nicotinic acid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Different types of lipoproteins have varied significance on cardiovascular disease. Low-density lipoproteins (LDL) are carriers of cholesterol. Excess cholesterol becomes deposited in blood vessel walls. The blood vessels are narrowed as a result and blood flow becomes compromised. When LDL is oxidised (combined with oxygen) or glycated (bound to glucose), the structure is altered. Altered LDL acts as a direct irritant to the vessel wall causing inflammation. Eventually the inflammatory damage to the blood vessels cannot be repaired. High-density lipoproteins (HDL) have a protective role in cardiovascular disease. HDL takes up cholesterol in the circulation and carries it to the liver where it is broken down. HDL is associated with an enzyme paraoxonase. The enzyme is thought to have an important role in preventing LDL from oxidation and glycation thus reducing its ability to be inflammatory. Therefore too much LDL is harmful to the body but high levels of HDL are advantageous. Dru;Secondary Objective: HDL is associated with the enzyme paraoxonase. The enzyme is thought to have an important role in preventing LDL oxidation and glycation. We will study the effects of tredaptive on levels of paraoxonase activity, oxidised LDL, glycated LDL and various markers of inflammation: e.g. cell adhesion molecules, serum amyloid A, hcCRP (C-reactive protein), TNF-alpha (tumour necrosis factor-alpha).;Primary end point(s): We expect the majority (90% or more) of patients to achieve a 15% increase in HDL level. | — |
Countries
United Kingdom
Outcome results
None listed