High-Density Lipoprotein (HDL) Treatment Study

This study has been completed.
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
First received: April 5, 2007
Last updated: June 2, 2008
Last verified: June 2008

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
Genetic Diseases, Inborn
Drug: Atorvastatin; Fenofibrate; Niacin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment Study for Severe High-Density Lipoprotein Deficiency

Resource links provided by NLM:

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • HDL cholesterol [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • apo AI [ Time Frame: 9 months ] [ Designated as safety issue: No ]

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)
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
  Show Detailed Description


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:

  • Triglycerides ≥ 5 mmol/L
  • Diabetes
  • Severe obesity (BMI ≥ 30)
  • Alcohol intake > 21 drinks/week
  • Untreated disease (thyroid, hepatic or renal)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458055

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

Additional Information:
Responsible Party: Jacques Genest MD, McGill University Hospital Center
ClinicalTrials.gov Identifier: NCT00458055     History of Changes
Other Study ID Numbers: MUHC-RI 0906 
Study First Received: April 5, 2007
Last Updated: June 2, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Lipid lowering agents
Drug treatment
Cellular cholesterol efflux

Additional relevant MeSH terms:
Coronary Artery Disease
Genetic Diseases, Inborn
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors
Vascular Diseases
Growth Substances
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents
Vitamin B Complex

ClinicalTrials.gov processed this record on May 24, 2016