Status:
COMPLETED
Type III Dysbetalipoproteinemia
Lead Sponsor:
AstraZeneca
Conditions:
Hyperlipoproteinemia Type III
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Evaluation of the efficacy of rosuvastatin 10mg, rosuvastatin 20mg and pravastatin 40mg in subjects with dysbetalipoproteinemia.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00214604
Start Date
February 1 2005
End Date
February 1 2007
Last Update
November 19 2010
Active Locations (2)
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1
Research Site
Oslo, Norway
2
Research Site
Cape Town, South Africa