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Trial record 7 of 9014 for:    Genetic Diseases, Inborn AND Genetic Diseases, Inborn

High-Density Lipoprotein (HDL) Treatment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00458055
Recruitment Status : Completed
First Posted : April 9, 2007
Last Update Posted : June 4, 2008
Information provided by:
McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Arteriosclerosis Hypoalphalipoproteinemias Genetic Diseases, Inborn Drug: Atorvastatin; Fenofibrate; Niacin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Study for Severe High-Density Lipoprotein Deficiency
Study Start Date : November 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Intervention Details:
  • Drug: Atorvastatin; Fenofibrate; Niacin
    Atorvastatin 20 mg; Fenofibrate 200 mg; Niacin 2g used sequentially for 8 weeks, after 4 weeks washout.
    Other Name: Lipotor; Tricor; Niaspan

Primary Outcome Measures :
  1. HDL cholesterol [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. apo AI [ Time Frame: 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- HDL deficiency (HDL-cholesterol < 5th percentile, age and gender-matched)

Exclusion Criteria:

  • Triglycerides ≥ 5 mmol/L
  • Diabetes
  • Severe obesity (BMI ≥ 30)
  • Alcohol intake > 21 drinks/week
  • Untreated disease (thyroid, hepatic or renal)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00458055

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Canada, Quebec
MUHC-Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
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Principal Investigator: Jacques Genest, MD McGill University Health Centre/Research Institute of the McGill University Health Centre

Additional Information:
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Responsible Party: Jacques Genest MD, McGill University Hospital Center Identifier: NCT00458055     History of Changes
Other Study ID Numbers: MUHC-RI 0906
First Posted: April 9, 2007    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008
Keywords provided by McGill University Health Centre/Research Institute of the McGill University Health Centre:
Lipid lowering agents
Drug treatment
Cellular cholesterol efflux
Additional relevant MeSH terms:
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Coronary Artery Disease
Genetic Diseases, Inborn
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Lipid Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Nicotinic Acids
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Vitamin B Complex