Hyperlipoproteinemia Type III
Conditions
Brief summary
Evaluation of the efficacy of rosuvastatin 10mg, rosuvastatin 20mg and pravastatin 40mg in subjects with dysbetalipoproteinemia.
Interventions
DRUGRosuvastatin
10mg
DRUGrosuvastatin
20mg
DRUGpravastatin
40mg
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Norway, South Africa
Outcome results
None listed