Can Atorvastatin Improve Vascular Function in Women With a History of Preeclampsia?

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to test the hypothesis that a short course of atorvastatin can improve vascular function in women with a history of preeclampsia, compared to placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Treatments: Atorvastatin; Atorvastatin Calcium

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.