Clinical trial • Phase III • Other

Pravastatin sodium for Intrauterine growth restriction | Preeclampsia

Phase III trial of Pravastatin sodium for Intrauterine growth restriction | Preeclampsia.

Overview

Trial Therapeutic Area
Other
Trial Disease
Intrauterine growth restriction | Preeclampsia
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
17-02-2025
First CTIS Authorization Date
13-06-2025

Trial design

Randomised, pravastatina kern pharma 40 mg oral daily (intervention) versus placebo pravastatina (placebo control; dose/schedule for placebo not specified). Phase III trial across 6 sites in Spain.

Randomised
Yes
Comparator
Pravastatina Kern Pharma 40 mg oral daily (intervention) versus Placebo Pravastatina (placebo control; dose/schedule for placebo not specified).
Target Sample Size
154

Eligibility

Recruits 154 Pregnant individuals are identified as a vulnerable population in the trial. Participants must be able to give informed consent ("Able to give informed consent."). Consent is obtained from the participant (no assent process for minors is described). Subject information and informed consent form documents are listed but specific language versions are not specified in the record..

Vulnerable Population
Pregnant individuals are identified as a vulnerable population in the trial. Participants must be able to give informed consent ("Able to give informed consent."). Consent is obtained from the participant (no assent process for minors is described). Subject information and informed consent form documents are listed but specific language versions are not specified in the record.

Inclusion criteria

  • {"criterion_text":"- Singleton fetus."}
  • {"criterion_text":"- Between 24+0 to 29+6 weeks of gestation at the inclusion"}
  • {"criterion_text":"- Early-onset severe PE: women with a diagnosis of severe-preterm PE who are candidates for expectant management and have no clinical indication for immediate delivery, based on the clinical assessments of the attending doctors."}
  • {"criterion_text":"- And/or IUGR: Diagnosis of early onset IUGR according to the SMFM classification with umbilical artery Doppler with absent/reversed diastolic flow; or estimated fetal weight <10th percentile plus pulsatility index (PI) of umbilical artery Doppler >95th percentil."}
  • {"criterion_text":"- Able to give informed consent."}

Exclusion criteria

  • {"criterion_text":"- Established maternal or fetal compromise that necessitated immediate delivery"}
  • {"criterion_text":"- Abnormal karyotype, structural abnormalities, or congenital infections."}
  • {"criterion_text":"- Treatment with pravastatin or other statins prior to inclusion."}
  • {"criterion_text":"- Active liver disease, including persistent and unexplained elevations of serum transaminases (3 times above the upper limit)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Days of prolongation of pregnancy between inclusion and delivery; continuous (days).","definition_or_measurement_approach":"Measured as the number of days between inclusion and delivery; treated as a continuous variable (days)."}

Recruitment

Planned Sample Size
154
Recruitment Window Months
32
Consent Approach
Informed consent must be given by the participant (pregnant individual). Inclusion criterion: "Able to give informed consent." Subject information and informed consent form (SIS and ICF) documents are included in the record (multiple versions) but specific languages or age-specific documents are not specified.

Geography

Total Number Of Sites
6
Total Number Of Participants
154

Spain

Earliest CTIS Part Ii Submission Date
26-05-2025
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
228
Number Of Sites
6
Number Of Participants
154

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Maternal-fetal medicine
Principal Investigator Name
Francesc Figueras Retuerta
Principal Investigator Email
ffiguera@clinic.cat
Contact Person Name
Francesc Figueras Retuerta
Contact Person Email
ffiguera@clinic.cat
Site Name
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Department Name
Internal medicine
Principal Investigator Name
Jaume Alijotas-Reig
Principal Investigator Email
communica@vhir.com
Contact Person Name
Jaume Alijotas-Reig
Contact Person Email
communica@vhir.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Gynecology
Principal Investigator Name
ELISA LLURBA
Principal Investigator Email
ELlurba@santpau.cat
Contact Person Name
ELISA LLURBA
Contact Person Email
ELlurba@santpau.cat
Site Name
Universitat Autonoma De Barcelona
Department Name
Social and Cultural Anthropology
Principal Investigator Name
Diana Marre
Principal Investigator Email
diana.marre@uab.cat
Contact Person Name
Diana Marre
Contact Person Email
diana.marre@uab.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Gynecology
Principal Investigator Name
Alberto Galindo Izquierdo
Principal Investigator Email
agalindo@salud.madrid.org
Contact Person Name
Alberto Galindo Izquierdo
Contact Person Email
agalindo@salud.madrid.org
Site Name
Hospital Sant Joan De Deu Barcelona
Department Name
Gynecology
Principal Investigator Name
Edurne Mazarico Gallego
Principal Investigator Email
edurne.mazarico@sjd.es
Contact Person Name
Edurne Mazarico Gallego
Contact Person Email
edurne.mazarico@sjd.es

Sponsor

Primary sponsor

Full Name
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Pravastatina Kern Pharma 40 mg comprimidos EFG
Active Substance
Pravastatin sodium
Modality
Small molecule
Routes Of Administration
ORAL
Route
oral
Authorisation Status
Authorised in ES (marketing authorisation number 65.939)
Starting Dose
40 mg
Dose Levels
40 mg
Frequency
daily
Maximum Dose
40 mg
Investigational Product Name
Placebo Pravastatina
Modality
Other

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