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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male participants must agree to use a condom and refrain from donating sperm
6MWD ≥ 100 and ≤ 550 meters repeated twice during Screening Period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial will test if a new drug helps treat pulmonary hypertension safely and effectively.
Who is the study for?
Adults diagnosed with pulmonary hypertension who can walk a certain distance and are already on stable PAH therapy may join. They must not have had major surgery or other clinical trials recently, no active cancer in the past 5 years, no severe heart issues, and their liver and kidney functions should be within specific limits. Women of childbearing age must use contraception; men must agree to use condoms.Check my eligibility
What is being tested?
The trial is testing LAM-001 as an additional treatment for those with pulmonary hypertension. It aims to see if adding LAM-001 to existing standard care improves patient outcomes compared to what's currently available without this new drug.See study design
What are the potential side effects?
While the side effects of LAM-001 aren't detailed here, similar drugs often cause symptoms like diarrhea, nausea, headache, rash or changes in blood test results that monitor liver function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use a condom and not donate sperm during the study.
Select...
I can walk between 100 and 550 meters without help.
Select...
I am 18 years old or older.
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My condition is a specific type of high blood pressure in the lungs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline VO2 max
Secondary outcome measures
Change from baseline in 6MWD
Change from baseline in RV SV, RV ESV, RV EDV, RV EF, RV SVI, RV ESVI, RV EDVI and RV mass by cardiac magnetic resonance (MR) imaging
Change from baseline in WHO functional class
+16 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: LAM-001Experimental Treatment1 Intervention
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Who is running the clinical trial?
OrphAI TherapeuticsLead Sponsor
6 Previous Clinical Trials
261 Total Patients Enrolled
AI Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
261 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a serious heart valve condition.Your heart's pumping ability is less than 45% on a special heart test.Your liver function tests show high levels of certain enzymes or bilirubin in your blood.I am using approved birth control methods if I can become pregnant.Your kidney function is very low, with a specific measure less than 30 mL/min/1.73 m2.You have had a serious allergic or anaphylactic reaction in the past.I am currently experiencing symptoms of heart disease.I have not had any cancer in the last 5 years.I agree to use a condom and not donate sperm during the study.I have not had a stroke in the last 3 months.You are expected to live for less than 12 months.I have been on a stable dose of PAH medication for at least 30 days.I or my family have a history of long QT syndrome or sudden heart death.I had a sudden worsening of heart failure within the last 30 days.I have taken more than 20 mg/day of prednisone in the last month.I have not had major surgery in the last 8 weeks.I can walk between 100 and 550 meters without help.I have received IV heart medication within the last 30 days.I have or haven't started treatment for pulmonary hypertension within the last 30 days.I have had a heart or heart-lung transplant.Your hemoglobin level is higher than 16.0 grams per deciliter within 28 days before the start of the study.I have not had a serious infection in the last 6 months.You need to have had a lung function test within the 6 months before the screening.I haven't taken sirolimus or similar drugs in the last 3 months.I had a heart procedure called atrial septostomy within the last 6 months.I have a history of heart muscle diseases that make it hard for my heart to fill with blood.I am 18 years old or older.My condition is a specific type of high blood pressure in the lungs.I have severe sleep apnea that I haven't treated.I have a history of tightness around my heart.I have a history of significant health issues not related to pulmonary arterial hypertension.You started a new exercise program for heart and lung rehab within the 90 days before the start of the study.My high blood pressure is not under control.
Research Study Groups:
This trial has the following groups:- Group 1: LAM-001
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is LAM-001 hazardous to individuals?
"Data collected thus far has suggested that LAM-001 is relatively safe, earning it a score of 2 on our scale. As this trial is in its Phase 2, there are few studies providing substantiated evidence for efficacy."
Answered by AI
Is enrollment open for this clinical experiment?
"Per clinicaltrials.gov, this medical trial is not accepting patients at the present moment. It was initially posted on March 31st 2023 and last edited on March 22nd 2023. Though, there are still 753 other trials actively looking for volunteers presently."
Answered by AI
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