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Angiotensin II Receptor Blocker
Losartan for Cystic Fibrosis
Phase 2
Waitlist Available
Led By Charles Bengtson, MD, MSc
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 12
Awards & highlights
Study Summary
This trial aims to see if using losartan in people with cystic fibrosis who are already on modulator therapy can improve the response of a specific channel in the body. Participants will take either
Who is the study for?
This trial is for individuals with cystic fibrosis who are currently receiving modulator therapy. Specific eligibility details aren't provided, but typically participants must meet certain health criteria and not have conditions that would exclude them from safely participating.Check my eligibility
What is being tested?
The study is testing whether losartan can improve the effectiveness of modulator therapy in cystic fibrosis patients by measuring changes in sweat chloride levels over twelve weeks. Participants will be randomly assigned to receive either losartan or a placebo.See study design
What are the potential side effects?
While specific side effects are not listed, common side effects of losartan may include dizziness due to low blood pressure, increased potassium levels, kidney function changes, and allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sweat chloride
Secondary outcome measures
Adverse events
CFQ-R
Inflammatory mediators - airway
+5 moreSide effects data
From 2021 Phase 4 trial • 227 Patients • NCT0218812143%
Laboratory values outside normal range
23%
Psychiatric Hospitalization
6%
Medical Hospitalization
2%
Elevated creatine kinase level
1%
Muscle pain
1%
Hypotension
1%
Dehydration
1%
Leukemia
1%
Placed on Lithium while on Losartan
100%
80%
60%
40%
20%
0%
Study treatment Arm
Statin and/or Angiotensin Receptor Blocker
Usual Treatment
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LosartanExperimental Treatment1 Intervention
Losartan 25mg twice daily for one week followed by 50mg twice daily through week 12.
Group II: PlaceboPlacebo Group1 Intervention
Placebo twice daily through week 12
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Losartan
2003
Completed Phase 4
~3000
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
464 Previous Clinical Trials
169,233 Total Patients Enrolled
8 Trials studying Cystic Fibrosis
221 Patients Enrolled for Cystic Fibrosis
Charles Bengtson, MD, MScPrincipal InvestigatorUniversity of Kansas Medical Center
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals currently able to participate in this research study?
"The information from clinicaltrials.gov reveals that this particular study, which was initially listed on May 1st, 2024 and last updated on April 10th, 2024, is no longer seeking participants. Nonetheless, there are currently 741 other trials actively enrolling eligible individuals at present."
Answered by AI
Has Losartan received approval from the FDA?
"As part of this Phase 2 study, Losartan has been assessed with a safety rating of 2 by our team at Power. This indicates that while there is evidence supporting its safety profile, efficacy data is yet to be established."
Answered by AI
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