Type III Dysbetalipoproteinemia - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00214604

Purpose

Evaluation of the efficacy of rosuvastatin 10mg, rosuvastatin 20mg and pravastatin 40mg in subjects with dysbetalipoproteinemia.

Condition	Intervention	Phase
Hyperlipoproteinemia Type III	Drug: Rosuvastatin 10mg Drug: rosuvastatin 20mg Drug: pravastatin 40mg	Phase III

Genetics Home Reference related topics: cholesteryl ester storage disease Farber lipogranulomatosis long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency

Drug Information available for: Pravastatin Pravastatin sodium Rosuvastatin Rosuvastatin calcium Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study
Official Title:	An 18-Week, Randomized, Multicenter, Phase 3b, Double-Blind, Crossover Study, Followed by an 18-Week Open-Label Period to Evaluate the Efficacy & Safety of the Lipid-Regulating Agents, Rosuvastatin & Pravastatin in the Treatment of Subjects With Dysbetalipoproteinemia (Frederickson Type III Hyperlipoproteinemia)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Percent change from baseline in non-HDL-C after 6 weeks of treatment at a given dose during the 18-week randomized crossover period.

Secondary Outcome Measures:

Efficacy of once daily treatment with rosuvastatin 10mg, rosuvastatin 20mg and provastatin 40mg in subjects with dysbetalipoproteinemia after 6 weeks of treatment at any given dose during the 18-week randomized crossover period.

Estimated Enrollment:	30
Study Start Date:	March 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of dysbetalipoproteinemia defined as VLDL-C/VLDL-TG mass ratio >0.35 at Visit 2 or the concurrence of mixed hyperlipidemia (fasting TC ≥ 200mg/dL, fasting TG ≥ 200mg/dL at Visits 2 and 3) and a genotype of ApoE published to be associated with dysbetalipoproteinemia

Exclusion Criteria:

Use of cholesterol-lowering drugs, lipid lowering dietary supplements or food additives after Visit 1 except in accordance with the protocol as co-administered therapy (i.e., a fenofibrate) with rosuvastatin 40mg at Weeks 30 to 36; current active liver disease or hepatic dysfunction, serum CK ≥ 3 times ULN (unless explained by exercise) anytime during dietary period, serum creatinine > 2.0 mg/dL or a history of renal transplantation before the treatment phase, fasting triglyceride > 1000 mg/dL at any time during the dietary lead-in or a history of pancreatitis while on treatment for dysbetalipoproteinemia.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214604

Locations

Norway
Research Site
Oslo, Norway
South Africa
Research Site
Cape Town, South Africa

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Crestor Medical Sciences Director, MD

AstraZeneca

More Information

Study ID Numbers:	D3560C00071
Study First Received:	September 21, 2005
Last Updated:	April 16, 2007
ClinicalTrials.gov Identifier:	NCT00214604
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors
Hyperlipoproteinemia Type III
Hyperlipidemias
Metabolic Diseases
Broad beta disease
Metabolism, Inborn Errors
Pravastatin

Rosuvastatin
Genetic Diseases, Inborn
Metabolic disorder
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009