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| Sponsor: | McGill University Health Center |
|---|---|
| Information provided by: | McGill University Health Center |
| ClinicalTrials.gov Identifier: | NCT00458055 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Coronary Arteriosclerosis Hypoalphalipoproteinemias Genetic Diseases, Inborn |
Drug: Atorvastatin; Fenofibrate; Niacin |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Treatment Study for Severe High-Density Lipoprotein Deficiency |
| Enrollment: | 19 |
| Study Start Date: | November 2006 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HDL deficiency (HDL-cholesterol < 5th percentile, age and gender-matched)
Exclusion Criteria:
Contacts and Locations| Canada, Quebec | |
| MUHC-Royal Victoria Hospital | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Principal Investigator: | Jacques Genest, MD | McGill University Health Center |
More Information
| Responsible Party: | McGill University Hospital Center ( Jacques Genest MD ) |
| Study ID Numbers: | MUHC-RI 0906 |
| Study First Received: | April 5, 2007 |
| Last Updated: | June 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00458055 History of Changes |
| Health Authority: | Canada: Ethics Review Committee |
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Lipid lowering agents Drug treatment Statin |
Fibrate Niacin Cellular cholesterol efflux |
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Lipid Metabolism, Inborn Errors Antimetabolites Vasodilator Agents Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Physiological Effects of Drugs Hypolipoproteinemias Arteriosclerosis Hypoalphalipoproteinemias Metabolism, Inborn Errors Vitamins Therapeutic Uses Cardiovascular Diseases Micronutrients Dyslipidemias |
Arterial Occlusive Diseases Vitamin B Complex Heart Diseases Metabolic Diseases Growth Substances Antilipemic Agents Vascular Diseases Enzyme Inhibitors Anticholesteremic Agents Cardiovascular Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Procetofen Pharmacologic Actions Coronary Disease Genetic Diseases, Inborn |