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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ a total of 1 time during the study, within ~4 weeks following enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a total of 1 time during the study, within ~4 weeks following enrollment
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 • NCT0438817617%
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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a skin condition.I am taking medication to lower my cholesterol.I am currently taking medication for high blood pressure.I gave birth between 12 weeks and 5 years ago.I am between 18 and 45 years old.
Research Study Groups:
This trial has the following groups:- Group 1: assessment of microvascular function
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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