Type III Dysbetalipoproteinemia
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperlipoproteinemia Type III
Intervention: Rosuvastatin 10mg (Drug); rosuvastatin 20mg (Drug); pravastatin 40mg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Crestor Medical Sciences Director, MD, Study Director, Affiliation: AstraZeneca
Summary
Evaluation of the efficacy of rosuvastatin 10mg, rosuvastatin 20mg and pravastatin 40mg in
subjects with dysbetalipoproteinemia.
Clinical Details
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)
Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study
Primary outcome: 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: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Research Site, Oslo, Norway
Research Site, Cape Town, South Africa
Additional Information
Starting date: March 2005
Last updated: April 16, 2007
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