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Angiotensin II Receptor Blocker

Losartan for Preeclampsia (LIVE-PE Trial)

Phase < 1
Recruiting
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
Must not have
diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR < 60 mL/min/1.73m2,
current antihypertensive medication,
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a total of 2 times throughout the study: 1) at the completion of 6 weeks of oral losartan treatment, and 2) at the completion of 6 weeks of placebo treatment

Summary

This trial will help us to understand how losartan may improve vascular function in women with a history of preeclampsia and give us insight into the mechanisms behind the increased risk of cardiovascular disease in these women.

Who is the study for?
This trial is for post-partum women over 18 who had preeclampsia in their last pregnancy within the past 24 months. Participants must be using birth control and not planning to get pregnant soon. They can't join if they have allergies to study drugs, use tobacco, have liver or metabolic diseases including CKD, had high blood pressure before pregnancy, gestational diabetes, are currently pregnant or breastfeeding, have skin diseases or a BMI under 18.5.
What is being tested?
The study tests whether Losartan Potassium improves vascular function in women who've experienced preeclampsia by comparing it with a placebo. It involves examining blood vessels in the skin and analyzing inflammatory responses after taking either the medication or placebo.
What are the potential side effects?
While specific side effects aren't listed here, Losartan may typically cause dizziness due to lowered blood pressure, mild stomach pain, diarrhea or heartburn among others. Placebo generally has no active effects but can lead to symptoms through expectation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have or might have a liver, metabolic disease, or kidney disease with reduced function.
Select...
I am currently taking medication for high blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a total of 2 times throughout the study: 1) at the completion of 6 weeks of oral losartan treatment, and 2) at the completion of 6 weeks of placebo treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and a total of 2 times throughout the study: 1) at the completion of 6 weeks of oral losartan treatment, and 2) at the completion of 6 weeks of placebo treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Central and Peripheral Vascular Stiffness following placebo
Central and Peripheral Vascular Stiffness following systemic AT1 receptor inhibition
Microvascular angiotensin II sensitivity following placebo
+3 more
Secondary study objectives
PBMC inflammatory sensitivity
circulating inflammatory cytokines

Side effects data

From 2014 Phase 3 trial • 608 Patients • NCT00429364
10%
Dizziness
10%
Headache
6%
Fatigue
5%
Chest pain
4%
Agitation
4%
Syncope
3%
Insomnia
3%
Depression
3%
Epistaxis
3%
Palpitations
3%
Back pain
2%
Anxiety
2%
Dyspnoea
2%
Nightmare
2%
Abdominal pain NOS
2%
Chest wall pain
2%
Pain in extremity
2%
Stomach discomfort
2%
Personality change
1%
Pneumonia
1%
Pruritus
1%
Infection with unknown ANC-upper ariway NOS
1%
Sinus infection
1%
Pneumothorax NOS
1%
Bronchospasm
1%
Urticaria NOS
1%
Convulsions NOS
1%
Sinusitis NOS
1%
Cough
1%
Dehydration
1%
Conjunctivitis
1%
Constipation
1%
Diarrhoea NOS
1%
Dysgeusia
1%
Nausea
1%
Vomiting NOS
1%
Pyrexia
1%
Arthralgia
1%
Myalgia
1%
Cognitive disorder
1%
Extrapyramidal disorder
1%
Syncope vasovagal
1%
Nasal congestion
1%
Acne NOS
1%
Raynaud's Phenomena
1%
Edema:head and neck
1%
Mononucleosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atenolol
Losartan

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LosartanExperimental Treatment1 Intervention
6 weeks of daily (50mg/day) oral losartan potassium tablet
Group II: PlaceboPlacebo Group1 Intervention
6 weeks of daily oral placebo tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Losartan Potassium
2007
Completed Phase 4
~1060

Find a Location

Who is running the clinical trial?

Anna Stanhewicz, PhDLead Sponsor
10 Previous Clinical Trials
402 Total Patients Enrolled

Media Library

Losartan Potassium (Angiotensin II Receptor Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04632589 — Phase < 1
Pre-eclampsia Research Study Groups: Losartan, Placebo
Pre-eclampsia Clinical Trial 2023: Losartan Potassium Highlights & Side Effects. Trial Name: NCT04632589 — Phase < 1
Losartan Potassium (Angiotensin II Receptor Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04632589 — Phase < 1
~4 spots leftby Nov 2025
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