PreeclampsiaPhase 1StatinNCT01717586
Pravastatin for Prevention of Preeclampsia
A Phase 1 study testing Pravastatin in people with Preeclampsia, run by The University of Texas Medical Branch, Galveston at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Pravastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2012to 12 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known chromosomal, genetic, or major fetal malformations, fetal demise, or planned termination
- Patients with contraindications for statin therapy:
- Hypersensitivity to pravastatin or any component of the product
- Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes (2 x normal of serum transaminases)
- History of myopathy or rhabdomyolysis
- Patients with any of the following conditions:
Show all 15Show fewer
- HIV positive
- Status post solid organ transplant
- Chronic renal disease/insufficiency with baseline serum creatinine ≥1.5 mg/dL
- Uterine malformations (didelphus, bicornuate, unicornate)
- Cancer
- Statin use in current pregnancy
- 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)
- Participating in another intervention study that influences the outcomes of this study
- Plans to deliver in a non-network site
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University
Chicago, Illinois, 60611
University of Texas Medical Branch
Galveston, Texas, 77555
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Pravastatin for the Prevention of Preeclampsia in High-Risk Women: A Phase I Pilot Study
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.
Read the detailed description
Preeclampsia shares pathogenic similarities with adult cardiovascular diseases as well as many risk factors. Endothelial dysfunction and inflammation are fundamental for the initiation and progression of both. There is strong evidence that 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins) are beneficial in primary and secondary prevention of cardiovascular mortality and other cardiovascular events. Biological plausibility as well as animal data supports a similar role for statins in preeclampsia.
Currently, there are no clinically available agents to prevent preeclampsia. However because of the below properties of statins, this class of medications could substantially contribute to preeclampsia prevention.
- Statins pleiotropic actions on various mechanisms: reversing the angiogenic imbalance by upregulating vascular endothelial growth factor (VEGF) and placental growth factor (PlGF), and reducing the antiangiogenic factors such as soluble fms-like tyrosine kinase-1 (sFlt-1) and soluble endoglin (sEng).
- Statins up regulation of endothelial nitric oxide synthase, leading to improved nitric oxide production in the vasculature and to activate the heme oxygenase-1/carbon monoxide (HO-1/CO) pathway, protecting the endothelium and reducing the inflammatory and oxidative insults.
The purpose of this pilot study is to evaluate the maternal-fetal safety and pharmacokinetic (PK) profiles of pravastatin when used in pregnant women at high-risk of developing preeclampsia.
- Conditions
- Preeclampsia
- Being tested
- Pravastatin, Placebo
- Keywords
- preeclampsia, pravastatin, Pravachol®, statin, high-risk pregnancy, safety, fetal morbidity and mortality, maternal morbidity and mortality, neonatal mortality, premature delivery, preemie
- Medical subject headings
- Pre-Eclampsia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PravastatinDrug
Also called pravastatin sodium, Brand name: Pravachol®
Comparison of different drug dosages. Women will be instructed to take a pravastatin pill everyday starting the day of randomization and ending the day of delivery. The women will be divided into three cohorts. Each cohort will receive one of the following doses of pills: 10mg or 20mg or 40mg.
PlaceboDrug
Women will be instructed to take a placebo pill daily beginning the day of randomization and ending the day of delivery.
| Study group | Role | What they receive |
|---|---|---|
| Pravastatin Group | Active comparator | Pregnant women at high-risk for preeclampsia who are taking pravastatin during their pregnancy. Receives: Drug: Pravastatin |
| Control Group | Placebo comparator | Pregnant women who are at high-risk for developing preeclampsia who are taking a placebo during their pregnancy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of maternal adverse events
The presence of side effects and adverse events will be assessed at each study visit by:
- a symptoms checklist
- any other report of adverse events
- at select visits: laboratory testing for liver function test(LFT) and creatine kinase(CK)
Measured: From the date of randomization until the date of delivery, assessed up to 210 days
Number and type of fetal/neonatal adverse events
The presence of adverse events will be assessed by evaluating
- Fetal and neonatal death
- Birthweight (including rate of small for gestational age)
- Apgar scores
- Congenital malformations
- Auditory brainstem response (ABR) evoked potential
- Cord blood lipid profile, AST/ALT, and CK levels
Measured: From date of birth up to discharge or 120 days after birth.
Pharmacokinetic parameters of pravastatin sodium during pregnancy
Timed blood and urine collection performed once between 18 wks 0 days GA and 23 wks 6 days GA and once between 30 wks 0 days GA and 33 wks 6 days GA.
Timed blood collection intervals: pre-dose(0)and 0.5hr, 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr post dose.
Time urine collection intervals: pre-dose (0) and 0-4hr, 4-8hr hr post dose.
Evaluation parameters:Maximum observed plasma concentration (Cmax) and peak time (Tmax), Steady-state area under the plasma concentration-time curve during the 24-h dosing interval (AUC0-24h), Steady-state apparent oral clearance (CL/F), Elimination half-life (t½), Renal clearance of pravastatin
Measured: Between Pre-dose (0) and 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startAug 2012
- Primary completion12 Feb 2024
- Study completion12 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Northwestern University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Maged Costantine, MD, Principal investigator, UTexasGalveston; Ohio State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717586
- Sponsor's protocol ID
- 12-097 OPRU/OPRC Pravastatin
- Other IDs
- U54HD047891
- Acronym
- Statin
- Status last verified
- May 2025
- First submitted
- 3 Jan 2012
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: per NICHD guidelines
Publications
Costantine MM, Cleary K, Hebert MF, Ahmed MS, Brown LM, Ren Z, Easterling TR, Haas DM, Haneline LS, Caritis SN, Venkataramanan R, West H, D'Alton M, Hankins G; Eunice Kennedy Shriver National Institute of Child Health and Human Development Obstetric-Fetal Pharmacology Research Units Network. Safety and pharmacokinetics of pravastatin used for the prevention of preeclampsia in high-risk pregnant women: a pilot randomized controlled trial. Am J Obstet Gynecol. 2016 Jun;214(6):720.e1-720.e17. doi: 10.1016/j.ajog.2015.12.038. Epub 2015 Dec 23.
PubMed 26723196Costantine MM, West H, Wisner KL, Caritis S, Clark S, Venkataramanan R, Stika CS, Rytting E, Wang X, Ahmed MS; Eunice Kennedy Shriver National Institute of Child Health and Human Development Obstetric-Fetal Pharmacology Research Centers (OPRC) Network, Bethesda, MD. A randomized pilot clinical trial of pravastatin versus placebo in pregnant patients at high risk of preeclampsia. Am J Obstet Gynecol. 2021 Dec;225(6):666.e1-666.e15. doi: 10.1016/j.ajog.2021.05.018. Epub 2021 May 24.
PubMed 34033812Costantine MM, Cleary K; Eunice Kennedy Shriver National Institute of Child Health and Human Development Obstetric--Fetal Pharmacology Research Units Network*. Pravastatin for the prevention of preeclampsia in high-risk pregnant women. Obstet Gynecol. 2013 Feb;121(2 Pt 1):349-353. doi: 10.1097/AOG.0b013e31827d8ad5.
PubMed 23344286Luque NM, Leader L, Lowe SM, Horrowitz SD, Tare M, Hinkley V, Matchkov VV, Costantine MM, Markus I, Liu L, Sandow SL, Murphy TV. Pravastatin Corrects Endothelial Dysfunction in Ex Vivo Uterine Radial Arteries in Preeclampsia. Acta Physiol (Oxf). 2026 Apr;242(4):e70186. doi: 10.1111/apha.70186.
PubMed 41808442Costantine MM, Clifton RG, Boekhoudt TM, Lawrence K, Gyamfi-Bannerman C, Wisner KL, Grobman W, Caritis SN, Simhan HN, Hebert MF, Longo M, Saade GR; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network and the Obstetric-Fetal Pharmacology Research Centers Network. Long-term neurodevelopmental follow-up of children exposed to pravastatin in utero. Am J Obstet Gynecol. 2023 Aug;229(2):153.e1-153.e12. doi: 10.1016/j.ajog.2023.02.016. Epub 2023 Feb 24.
PubMed 36842489
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pravastatin for the Prevention of Preeclampsia in High-Risk Women: A Phase I Pilot Study
- ClinicalTrials.gov ID
- NCT01717586
- Acronym / sponsor ID
- Statin / 12-097 OPRU/OPRC Pravastatin
- Conditions
- Preeclampsia
- Keywords
- preeclampsia, pravastatin, Pravachol®, statin, high-risk pregnancy, safety, fetal morbidity and mortality, maternal morbidity and mortality
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Northwestern University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2012 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preeclampsia shares pathogenic similarities with adult cardiovascular diseases as well as many risk factors. Endothelial dysfunction and inflammation are fundamental for the initiation and progression of both. There is strong evidence that 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins) are beneficial in primary and secondary prevention of cardiovascular mortality and other cardiovascular events. Biological plausibility as well as animal data supports a similar role for statins in preeclampsia.
Currently, there are no clinically available agents to prevent preeclampsia. However because of the below properties of statins, this class of medications could substantially contribute to preeclampsia prevention.
- Statins pleiotropic actions on various mechanisms: reversing the angiogenic imbalance by upregulating vascular endothelial growth factor (VEGF) and placental growth factor (PlGF), and reducing the antiangiogenic factors such as soluble fms-like tyrosine kinase-1 (sFlt-1) and soluble endoglin (sEng).
- Statins up regulation of endothelial nitric oxide synthase, leading to improved nitric oxide production in the vasculature and to activate the heme oxygenase-1/carbon monoxide (HO-1/CO) pathway, protecting the endothelium and reducing the inflammatory and oxidative insults.
The purpose of this pilot study is to evaluate the maternal-fetal safety and pharmacokinetic (PK) profiles of pravastatin when used in pregnant women at high-risk of developing preeclampsia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pravastatin Group | Active comparator | Drug: PravastatinPregnant women at high-risk for preeclampsia who are taking pravastatin during their pregnancy. |
| Control Group | Placebo comparator | Drug: PlaceboPregnant women who are at high-risk for developing preeclampsia who are taking a placebo during their pregnancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- Known chromosomal, genetic, or major fetal malformations, fetal demise, or planned termination
- Patients with contraindications for statin therapy:
- Hypersensitivity to pravastatin or any component of the product
- Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes (2 x normal of serum transaminases)
- History of myopathy or rhabdomyolysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PravastatinAlso: pravastatin sodium, Brand name: Pravachol®Comparison of different drug dosages. Women will be instructed to take a pravastatin pill everyday starting the day of randomization and ending the day of delivery. The women will be divided into three cohorts. Each cohort will receive one of the following doses of pills: 10mg or 20mg or 40mg. | Drug | Pravastatin Group |
| PlaceboWomen will be instructed to take a placebo pill daily beginning the day of randomization and ending the day of delivery. | Drug | Control Group |
Primary outcome
Number and type of maternal adverse events
Time frame: From the date of randomization until the date of delivery, assessed up to 210 days
The presence of side effects and adverse events will be assessed at each study visit by: * a symptoms checklist * any other report of adverse events * at select visits: laboratory testing for liver function test(LFT) and creatine kinase(CK)
Number and type of fetal/neonatal adverse events
Time frame: From date of birth up to discharge or 120 days after birth.
The presence of adverse events will be assessed by evaluating * Fetal and neonatal death * Birthweight (including rate of small for gestational age) * Apgar scores * Congenital malformations * Auditory brainstem response (ABR) evoked potential * Cord blood lipid profile, AST/ALT, and CK levels
Pharmacokinetic parameters of pravastatin sodium during pregnancy
Time frame: Between Pre-dose (0) and 24 hours post dose
Timed blood and urine collection performed once between 18 wks 0 days GA and 23 wks 6 days GA and once between 30 wks 0 days GA and 33 wks 6 days GA. Timed blood collection intervals: pre-dose(0)and 0.5hr, 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr post dose. Time urine collection intervals: pre-dose (0) and 0-4hr, 4-8hr hr post dose. Evaluation parameters:Maximum observed plasma concentration (Cmax) and peak time (Tmax), Steady-state area under the plasma concentration-time curve during the 24-h dosing interval (AUC0-24h), Steady-state apparent oral clearance (CL/F), Elimination half-life (t½), Renal clearance of pravastatin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Background: PubMed 26723196Costantine MM, Cleary K, Hebert MF, Ahmed MS, Brown LM, Ren Z, Easterling TR, Haas DM, Haneline LS, Caritis SN, Venkataramanan R, West H, D'Alton M, Hankins G; Eunice Kennedy Shriver National Institute of Child Health and Human Development Obstetric-Fetal Pharmacology Research Units Network. Safety and pharmacokinetics of pravastatin used for the prevention of preeclampsia in high-risk pregnant women: a pilot randomized controlled trial. Am J Obstet Gynecol. 2016 Jun;214(6):720.e1-720.e17. doi: 10.1016/j.ajog.2015.12.038. Epub 2015 Dec 23.
- Background: PubMed 34033812Costantine MM, West H, Wisner KL, Caritis S, Clark S, Venkataramanan R, Stika CS, Rytting E, Wang X, Ahmed MS; Eunice Kennedy Shriver National Institute of Child Health and Human Development Obstetric-Fetal Pharmacology Research Centers (OPRC) Network, Bethesda, MD. A randomized pilot clinical trial of pravastatin versus placebo in pregnant patients at high risk of preeclampsia. Am J Obstet Gynecol. 2021 Dec;225(6):666.e1-666.e15. doi: 10.1016/j.ajog.2021.05.018. Epub 2021 May 24.
- Background: PubMed 23344286Costantine MM, Cleary K; Eunice Kennedy Shriver National Institute of Child Health and Human Development Obstetric--Fetal Pharmacology Research Units Network*. Pravastatin for the prevention of preeclampsia in high-risk pregnant women. Obstet Gynecol. 2013 Feb;121(2 Pt 1):349-353. doi: 10.1097/AOG.0b013e31827d8ad5.
- Derived from this study: PubMed 41808442Luque NM, Leader L, Lowe SM, Horrowitz SD, Tare M, Hinkley V, Matchkov VV, Costantine MM, Markus I, Liu L, Sandow SL, Murphy TV. Pravastatin Corrects Endothelial Dysfunction in Ex Vivo Uterine Radial Arteries in Preeclampsia. Acta Physiol (Oxf). 2026 Apr;242(4):e70186. doi: 10.1111/apha.70186.
- Derived from this study: PubMed 36842489Costantine MM, Clifton RG, Boekhoudt TM, Lawrence K, Gyamfi-Bannerman C, Wisner KL, Grobman W, Caritis SN, Simhan HN, Hebert MF, Longo M, Saade GR; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network and the Obstetric-Fetal Pharmacology Research Centers Network. Long-term neurodevelopmental follow-up of children exposed to pravastatin in utero. Am J Obstet Gynecol. 2023 Aug;229(2):153.e1-153.e12. doi: 10.1016/j.ajog.2023.02.016. Epub 2023 Feb 24.
- Individual participant dataSharing planned: No. per NICHD guidelines
Related trials for Preeclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maged Costantine, MD principal investigator
UTexasGalveston; Ohio State
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pravastatin in people with Preeclampsia, run by The University of Texas Medical Branch, Galveston at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and type of maternal adverse events (time frame: From the date of randomization until the date of delivery, assessed up to 210 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01717586, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.