NCT01717586CompletedPhase 1
Pravastatin for Prevention of Preeclampsia
Pravastatin for the Prevention of Preeclampsia in High-Risk Women: A Phase I Pilot Study
Source: ClinicalTrials.gov · Last updated 4 May 2025
Brief summary (registry, in English)
The primary purpose of this pilot study is to determine the pharmacokinetic (PK) parameters and collect preliminary safety data for pravastatin when used as a prophylactic daily treatment in pregnant women at high risk of preeclampsia.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 3 Jan 2012
- Start date
- 1 Aug 2012
- Primary completion date
- 12 Feb 2024
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- NCT number
- NCT01717586
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 48
- From 1 Aug 2012 to the primary completion date, 12 Feb 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with contraindications for statin therapy:
- Status post solid organ transplant
- Current use of medications with potential drug interactions with statins, such as cyclosporine, fibrates, gemfibrozil, niacin, erythromycin, fluconazole, itraconazole, cholestyramine, digoxin, rifampin (patients will not be excluded if the drug has been discontinued, or is prescribed for a short duration of time)
Other illness
- Hypersensitivity to pravastatin or any component of the product
- History of myopathy or rhabdomyolysis
- Patients with any of the following conditions:
- HIV positive
- Cancer
Lab values
- Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes (2 x normal of serum transaminases)
- Chronic renal disease/insufficiency with baseline serum creatinine ≥1.5 mg/dL
Other
- Known chromosomal, genetic, or major fetal malformations, fetal demise, or planned termination
- Uterine malformations (didelphus, bicornuate, unicornate)
- Statin use in current pregnancy
- Participating in another intervention study that influences the outcomes of this study
- Plans to deliver in a non-network site
Who the study is looking for
- Documented history (review of chart or delivery note) of prior severe early onset PE in a prior pregnancy and requiring delivery ≤340/7 weeks' gestation. If in the index pregnancy, the woman was induced at the upper limit of 34 0/7 weeks of pregnancy and delivered within 48 hours in the same hospitalization, that woman could be enrolled. Women with severe PE in a pregnancy remote (greater than 2 pregnancies removed) from the current pregnancy do not qualify.
- 18 years or older with the ability to give informed consent
- Singleton pregnancy
- Normal serum transaminase (ALT and AST) concentrations in the last 6-months
- Gestational age (GA) between 12 weeks 0 days to 16 weeks 6 days based on clinical information and confirmed by an ultrasound per study procedures.
- Willingness to participate in planned PK study visits
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Texas Medical Branch Coordinator of this site? Confirm its status | Galveston | United States | Unknown status |
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.