Type III Dysbetalipoproteinemia
Phase 3
Completed
- Conditions
- Hyperlipoproteinemia Type III
- Registration Number
- NCT00214604
- Lead Sponsor
- AstraZeneca
- Brief Summary
Evaluation of the efficacy of rosuvastatin 10mg, rosuvastatin 20mg and pravastatin 40mg in subjects with dysbetalipoproteinemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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 β₯ 200mg/dL, fasting TG β₯ 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 β₯ 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Research Site
πΏπ¦Cape Town, South Africa