CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
Atorvastatin; Fenofibrate; Niacindrug
Likely dose
Atorvastatin; Fenofibrate; Niacin 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00458055
NCT00458055N/ACompleted

Treatment Study for Severe High-Density Lipoprotein Deficiency

In Brief

A clinical study evaluating Atorvastatin; Fenofibrate; Niacin for Coronary Arteriosclerosis and 2 related conditions. Completed, enrolled 19 participants across 1 site.

Detailed Summary

A low level of plasma high-density lipoprotein (HDL) cholesterol, "the good cholesterol", is the most common lipid abnormality observed in patients with a premature atherosclerotic cardiovascular disease. HDL carry excess cholesterol from peripheral tissues to the liver to be metabolized or excreted, a process known as reverse cholesterol transport. Epidemiological studies have shown an inverse correlation between plasma levels of HDL cholesterol and the risk of cardiovascular disease. An increase in plasma HDL cholesterol levels by 1 mg/dL may reduce the risk of cardiovascular disease by 2 to 3%. The standard care of treatment for a low level of HDL cholesterol is: 1) lifestyle modifications including exercise, smoking cessation, weight control, moderate alcohol intake and decreased dietary fat intake - all patients are encouraged to follow these lifestyle modifications; 2) medications which can raise HDL cholesterol. Currently used medications to treat lipid disorders can increase, in some extent, HDL cholesterol. These include niacin (vitamin B3), fibric acid derivatives (fibrates) and statins. However there is no data on the effect of these medications on severe cases of HDL deficiency. This project aims to determine whether currently available medications, used in standard medical practice for the treatment of lipoprotein disorders, can substantially increase HDL cholesterol in severe cases of HDL deficiencies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2007
Enrollment StartNov 1, 2006
Primary CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.2 years ago

Interventions

Atorvastatin; Fenofibrate; Niacindrug

Atorvastatin 20 mg; Fenofibrate 200 mg; Niacin 2g used sequentially for 8 weeks, after 4 weeks washout.