Can atorvastatin improve vascular function in women with a history preeclampsia? A Randomised, double-blinded, placebo-controlled crossover trial of atorvastatin in women with a history of preeclampsia. - Preeclampsia Vascular Studies Project 3 PVS3

Phase 1

• Conditions: Cardiovascular disease in women with a history of preeclampsia; MedDRA version: 13.1 Level: LLT Classification code 10047063 Term: Vascular disorder peripheral System Organ Class: 10047065 - Vascular disorders

• Registration Number: EUCTR2008-005759-21-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-21
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Participant must • be willing and able to give informed consent for participation in the study. • female, aged 18 -50 years • have been 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) [ISSHP Definition] • be willing, if of child bearing potential, to ensure that they or their partner use effective contraception during the study and for 4 weeks after, as defined in ICH (M3) (i.e. methods of birth control which result in a low failure rate of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner) • be willing to undertake urine pregnancy test at the start of each 4 week phase of the study to exclude unintended pregnancy. • have clinically acceptable laboratory markers of renal, thyroid and hepatic function at enrolment. •be able (in the Investigator’s opinion) and willing to comply with all study requirements. •be willing to allow her General Practitioner and consultant, if appropriate, to be notified of participation in the study and results of clinical laboratory tests.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 Participants must NOT have •Significant renal or hepatic impairment •Significant cardiovascular disease, diabetes mellitus or would have clinical indication(s) for receiving statin therapy (Framingham Risk Score >20%) •Scheduled elective surgery or other procedures requiring general anaesthesia during the study. •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified