Type III Dysbetalipoproteinemia
This study has been completed.
Information provided by:
First received: September 21, 2005
Last updated: November 18, 2010
Last verified: November 2010
Evaluation of the efficacy of rosuvastatin 10mg, rosuvastatin 20mg and pravastatin 40mg in subjects with dysbetalipoproteinemia.
Hyperlipoproteinemia Type III
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|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)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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:
- 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.
|Study Start Date:||February 2005|
|Study Completion Date:||February 2007|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
Other Name: CrestorDrug: rosuvastatin
Other Name: CrestorDrug: pravastatin
Other Name: Pravachol
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214604
|Cape Town, South Africa|
Sponsors and Collaborators
|Study Director:||AstraZeneca Crestor Medical Sciences Director, MD||AstraZeneca|