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Trial record 4 of 7844 for:    "Genetic Diseases, Inborn" [DISEASE]

High-Density Lipoprotein (HDL) Treatment Study

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ClinicalTrials.gov Identifier: NCT00458055
Recruitment Status : Completed
First Posted : April 9, 2007
Last Update Posted : June 4, 2008
Sponsor:
Information provided by:
McGill University Health Center

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

  Show Detailed Description

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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00458055


Locations
Canada, Quebec
MUHC-Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Jacques Genest, MD McGill University Health Center

Additional Information:
Publications:
Responsible Party: Jacques Genest MD, McGill University Hospital Center
ClinicalTrials.gov 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 Center:
Lipid lowering agents
Drug treatment
Statin
Fibrate
Niacin
Cellular cholesterol efflux

Additional relevant MeSH terms:
Genetic Diseases, Inborn
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Hypoalphalipoproteinemias
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Hypolipoproteinemias
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Fenofibrate
Niacin
Niacinamide
Nicotinic Acids
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Vitamin B Complex