Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT01278459
Eligibility Criteria:
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study.
* Diagnosed with preeclampsia during index pregnancy: defined as (1) new onset hypertension (\>140/90 mmHg) after 20 weeks gestation and (2) proteinuria (\>0.3g protein/24 hours).
* Participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 4 weeks after.
* Participants must be willing to undertake urine pregnancy test at the start of each 4 week phase of the study to exclude unintended pregnancy.
* Participants must have clinically acceptable laboratory markers of renal, thyroid and hepatic function at enrolment.
* Able (in the Investigator's opinion) and willing to comply with all study requirements.
* Willing to allow her General Practitioner and consultant, if appropriate, to be notified of participation in the study and results of clinical laboratory tests.
Exclusion Criteria:
Participants must not be
* Pregnant, lactating during the course of the study.
* Planning pregnancy during course of study or in 4 weeks after study completion
* Taking other medication, whether prescribed or over-the-counter, in the four weeks before first study dose and during the study other than for example mild analgesia or hormonal contraception.
* Taking vitamin medications that may interact with atorvastatin (e.g. niacin, Vitamin D)
* Terminally ill or is inappropriate for placebo medication
* Planning to undertake donation of blood during the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01278459
Study Brief:
Protocol Section:
NCT01278459