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Angiotensin Receptor Blocker
Losartan for Arthrofibrosis
Phase 4
Waitlist Available
Led By Joshua Rozell, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post-surgery
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing if Losartan, a blood pressure medication, can help reduce scar tissue and stiffness in patients after knee replacement surgery. It aims to improve movement and reduce the need for additional surgeries. Losartan has been studied for various effects including reducing blood pressure and improving heart function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days post-surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post-Operative Range of Motion (ROM)
Post-Operative Rate of Manipulation under Anesthesia (MUA)
Side 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
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Losartan GroupExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention
No additional steps in management are required for the control arm of the study.
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?
NYU Langone HealthLead Sponsor
1,413 Previous Clinical Trials
855,750 Total Patients Enrolled
Joshua Rozell, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You recently had surgery for a broken bone, infection, or cancer.You are currently taking medication for high blood pressure called ACE-inhibitor or Angiotensin receptor blocker.You have had previous surgery to correct the same issue being studied.You have been diagnosed with arthritis caused by a previous injury.You have been diagnosed with osteoarthritis or inflammatory arthritis and need a knee replacement surgery.You have a medical condition that makes it unsafe for you to take Losartan.
Research Study Groups:
This trial has the following groups:- Group 1: Losartan Group
- Group 2: Control Group
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.