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HMG-CoA reductase inhibitor

Pravastatin for Preeclampsia (Pravastatin Trial)

Phase 3
Waitlist Available
Led By Rebecca Clifton, PhD
Research Sponsored by The George Washington University Biostatistics Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
16 years or older at time of consent with ability to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years of age
Awards & highlights

Pravastatin Trial Summary

This trial will test whether pravastatin can reduce the rate of preeclampsia, fetal loss and maternal death in high-risk women.

Who is the study for?
This trial is for high-risk pregnant women aged 16 or older who have had preeclampsia with preterm delivery before 34 weeks. They must be between 12 and nearly 17 weeks pregnant, with normal liver function, not on certain medications, and planning to deliver at a network site.Check my eligibility
What is being tested?
The study tests if pravastatin can prevent preeclampsia in high-risk pregnancies. It's a double-blind trial where half the participants get pravastatin and the other half get a placebo daily until delivery, with follow-ups postpartum and for children up to age five.See study design
What are the potential side effects?
Pravastatin may cause side effects like muscle pain, nausea, headache, constipation or diarrhea. Serious side effects include liver problems and muscle issues that can lead to kidney failure (rare).

Pravastatin Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 16 or older and can make my own medical decisions.

Pravastatin Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pre-Eclampsia
Secondary outcome measures
BMI for age at 24 corrected months and 5 years
Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite score at 5 years
Birth weight
+38 more

Side effects data

From 2013 Phase 4 trial • 252 Patients • NCT01301066
2%
Headache
2%
Upper abdominal pain
2%
Blood CK increased
2%
Diarrhoea
2%
Fatigue
1%
Diverticulitis
1%
Atrial septal defect
1%
Enterovesical fistula
1%
Transient ischaemic attack
1%
Multiple fractures
1%
Respiratory failure
1%
Chronic obstructive pulmonary disease
1%
Chest pain
1%
Gastroenteritis
1%
Gastroenteritis viral
1%
Herpes dermatitis
1%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pitavastatin 4 mg QD
Pravastatin 40 mg QD

Pravastatin Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PravastatinExperimental Treatment1 Intervention
20 mg pravastatin daily
Group II: PlaceboPlacebo Group1 Intervention
Identical appearing daily placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pravastatin
2010
Completed Phase 4
~11530

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,814 Previous Clinical Trials
47,289,325 Total Patients Enrolled
The George Washington University Biostatistics CenterLead Sponsor
23 Previous Clinical Trials
101,410 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,952 Previous Clinical Trials
2,659,294 Total Patients Enrolled

Media Library

Pravastatin (HMG-CoA reductase inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03944512 — Phase 3
Prophylaxis of Preeclampsia Research Study Groups: Pravastatin, Placebo
Prophylaxis of Preeclampsia Clinical Trial 2023: Pravastatin Highlights & Side Effects. Trial Name: NCT03944512 — Phase 3
Pravastatin (HMG-CoA reductase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03944512 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count for this experiment?

"Although this trial is no longer active, it is worth noting that there are 115 clinical trials for obstetric labor complications and 12 for Pravastatin that are currently looking for participants."

Answered by AI

What are some other similar studies to this one that have been done in the past?

"Pravastatin has been researched since 2009 by Eiger BioPharmaceuticals. The first trial, involving 85 patients, completed in 2009. Pravastatin received its Phase 2 drug approval following the first trial in 2009. As of now, there are 12 live studies for Pravastatin being conducted across 45 cities and 11 countries."

Answered by AI

What are some of Pravastatin's most popular applications?

"Pravastatin is frequently used in secondary prevention and has additional benefits for treating cardiovascular disease, low-density lipoproteins, and coronary heart disease."

Answered by AI

What other scientific research has been undertaken to explore Pravastatin's medical benefits?

"Pravastatin was first investigated in 2009 at Children's Hospital Boston. To date, there have been 18320 completed clinical trials and there are presently 12 live trials. A large concentration of these trials are being conducted in Chicago, Illinois."

Answered by AI

Has Pravastatin been cleared by the FDA?

"Pravastatin is considered safe and was given a score of 3. This is because there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

In how many medical facilities is this research project being conducted?

"In addition to locations at Northwestern University, Columbia University, and Brown University, this trial is also being conducted at 11 other sites across the country."

Answered by AI
~491 spots leftby Jun 2026