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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
Must not have
Known diagnosis of significant valvular disease
Current symptomatic coronary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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I can walk between 100 and 550 meters without help.
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I am 18 years old or older.
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My condition is a specific type of high blood pressure in the lungs.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with a serious heart valve condition.
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I am currently experiencing symptoms of heart disease.
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I have not had any cancer in the last 5 years.
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I or my family have a history of long QT syndrome or sudden heart death.
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I have not had major surgery in the last 8 weeks.
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I have received IV heart medication within the last 30 days.
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I have had a heart or heart-lung transplant.
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I haven't taken sirolimus or similar drugs in the last 3 months.
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I have a history of heart muscle diseases that make it hard for my heart to fill with blood.
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I have severe sleep apnea that I haven't treated.
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I have a history of tightness around my heart.
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My high blood pressure is not under control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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: LAM-001Experimental Treatment1 Intervention
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Who is running the clinical trial?
OrphAI TherapeuticsLead Sponsor
6 Previous Clinical Trials
265 Total Patients Enrolled
AI Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
265 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.
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