The Pravastatin (Statin) study is a multi-center double-blinded randomized controlled trial designed to determine the PK parameters (during pregnancy compared with postpartum) and collect preliminary safety data for pravastatin (20 mg) when used as a prophylactic daily treatment in pregnant women at high risk of PE. The current study represents the second cohort of an exploratory dose finding and escalating controlled study of prophylactic daily pravastatin treatment in pregnant women at high risk of PE randomized to either pravastatin or placebo. The escalation of the dose to 20 mg, is included in the original IND (IND 114205) approved application and is necessary in order to identify the optimal pravastatin dose with the greatest effect and least risk profile. The NICHD Obstetric-Fetal Pharmacology Center includes a group of clinical centers recognized for their expertise in perinatal medicine, will collaborate in this study. The University of Texas Medical Branch (UTMB) serves as the lead clinical site for this study under the direction of the principal investigator. Each clinical center will have a clinical primary investigator who is responsible for overseeing the conduct of the study at her/his clinical center.
|Effective start/end date||3/1/17 → 6/30/17|
- University of Texas Medical Branch at Galveston (17-044//5U54HD047891-12 REVISED)
- National Institute of Child Health and Human Development (17-044//5U54HD047891-12 REVISED)