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Compound 21 for Preeclampsia

Phase < 1
Recruiting
Led By Anna Reid-Stanhewicz, PhD
Research Sponsored by Anna Stanhewicz, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a total of 1 time during the study, within ~4 weeks following enrollment
Awards & highlights
No Placebo-Only Group

Summary

This trial will help identify mechanisms of long-term blood vessel damage in women who have had preeclampsia, which can lead to better clinical management of cardiovascular disease risk.

Who is the study for?
This trial is for women aged 18-45 who experienced preeclampsia between 12 weeks and 5 years ago. It's also open to those who had healthy pregnancies. Participants should not be currently pregnant, planning pregnancy, have a history of hypertension or metabolic disease before pregnancy, use tobacco, or take certain medications like antihypertensives or statins.
What is being tested?
The study tests Compound 21 on the microvascular function in the skin of women post-preeclampsia. Researchers are investigating if activating angiotensin II receptors can repair blood vessel damage caused by preeclampsia and reduce future cardiovascular disease risk.
What are the potential side effects?
While specific side effects of Compound 21 aren't detailed here, similar studies may involve minor reactions at the drug delivery site (skin), potential allergic responses to the compound or materials used during testing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a total of 1 time during the study, within ~4 weeks following enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and a total of 1 time during the study, within ~4 weeks following enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in microvascular blood flow response to local compound 21 treatment measured by laser-Doppler flowmetry
Change in microvascular endothelial function following local C21 treatment compared to placebo treatment measured by laser-Doppler flowmetry
Secondary study objectives
Angiotensin receptor expression in endothelial cells

Side effects data

From 2020 Phase 2 trial • 20 Patients • NCT04388176
17%
Urinary tract infection
8%
Back pain
8%
Musculoskeletal chest pain
8%
Tremor
8%
Tinnitus
8%
Abdominal pain
8%
Skin tightness
100%
80%
60%
40%
20%
0%
Study treatment Arm
C21 200 mg
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: assessment of microvascular functionExperimental Treatment1 Intervention
The investigators use intradermal microdialysis to deliver compound 21 and L-NAME to the cutaneous microvasculature

Find a Location

Who is running the clinical trial?

Anna Stanhewicz, PhDLead Sponsor
10 Previous Clinical Trials
392 Total Patients Enrolled
Anna Reid-Stanhewicz, PhDPrincipal InvestigatorUniversity of Iowa

Media Library

assessment of microvascular function Clinical Trial Eligibility Overview. Trial Name: NCT05937841 — Phase < 1
Pre-eclampsia Research Study Groups: assessment of microvascular function
Pre-eclampsia Clinical Trial 2023: assessment of microvascular function Highlights & Side Effects. Trial Name: NCT05937841 — Phase < 1
assessment of microvascular function 2023 Treatment Timeline for Medical Study. Trial Name: NCT05937841 — Phase < 1
~7 spots leftby Jun 2025
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