Type III Dysbetalipoproteinemia - Full Text View

Sponsor:	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

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)

Resource links provided by NLM:

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis primary carnitine deficiency

Drug Information available for: Pravastatin Pravastatin sodium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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
Study Completion Date:	February 2007

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

No publications provided

Study ID Numbers:	D3560C00071
Study First Received:	September 21, 2005
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00214604 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Lipid Metabolism, Inborn Errors
Hyperlipoproteinemia Type III
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions
Metabolism, Inborn Errors
Pravastatin
Rosuvastatin
Genetic Diseases, Inborn
Therapeutic Uses
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010