Type III Dysbetalipoproteinemia (NCT00214604) | Clinical Trial Compass
CompletedPhase 3
Type III Dysbetalipoproteinemia
Norway, South Africa30 participantsStarted 2005-02
Plain-language summary
Evaluation of the efficacy of rosuvastatin 10mg, rosuvastatin 20mg and pravastatin 40mg in subjects with dysbetalipoproteinemia.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Percent change from baseline in non-HDL-C after 6 weeks of treatment at a given dose during the 18-week randomized crossover period.