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LTP001 for Pulmonary Arterial Hypertension
Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Resting mean pulmonary arterial pressure (mPAP) > 25 mmHg; pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure < 15 mmHg, as determined by right heart catheterization within 20 days of randomization
Be older than 18 years old
Must not have
Acute or chronic impairment (other than dyspnea), which would limit the ability to comply with study requirements, including interference with physical activity and execution of study procedures such as 6MWT (e.g., angina pectoris, claudication, musculoskeletal disorder, multiple sclerosis, need for walking aids)
Participants with pulmonary hypertension (PH) in the Clinical Classification Groups 2-5 (WHO), and any PAH Group 1 subgroups not covered by Inclusion Criterion #4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 5, 13 and 25
Awards & highlights
Summary
This trial is testing a new medication called LTP001 to see if it can help adults with high blood pressure in their lung arteries. The medication likely works by lowering the pressure in these arteries, making it easier for the heart to pump blood.
Who is the study for?
This trial is for people with pulmonary arterial hypertension (PAH) who are in WHO Functional Class II-III, have a specific level of pulmonary vascular resistance, and belong to certain PAH subgroups. They must be able to walk a certain distance and be on stable standard care therapy for PAH.
What is being tested?
The study tests the effectiveness and safety of LTP001 compared to a placebo in improving conditions for those with PAH. Participants will either receive LTP001 or a placebo without knowing which one they're getting.
What are the potential side effects?
While the side effects of LTP001 are not detailed here, common side effects from similar treatments may include headache, dizziness, nausea, diarrhea, rash or swelling at injection sites.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's pressure readings meet specific criteria from a recent test.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any health issues that would stop me from doing physical activities required in the study.
Select...
I have pulmonary hypertension but not from the heart's left side.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 5, 13 and 25
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 5, 13 and 25
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 right heard catheterization Pulmonary vascular resistance (PVR) at week 25
Secondary outcome measures
Change from baseline in Cardiac Output (CO) at week 25
Change from baseline in EmPHasis-10
Change from baseline in N-terminal fragment of the prohormone B-type natriuetic peptide (NT-ProBNP)
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LTP001Experimental Treatment1 Intervention
Participants will receive LTP001 orally once daily in the morning for approximately 24 weeks
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LTP001
2023
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,874 Previous Clinical Trials
4,199,944 Total Patients Enrolled
10 Trials studying Pulmonary Arterial Hypertension
518 Patients Enrolled for Pulmonary Arterial Hypertension
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a specific type of high blood pressure in the lungs related to genetics, heart defects, or certain drug use.My heart test shows high pressure in the lungs' blood vessels.You have limitations in physical activity and may experience some discomfort with normal activity.I do not have any health issues that would stop me from doing physical activities required in the study.I can walk between 150 and 550 meters in 6 minutes.My lung function tests show I have severe breathing issues.My heart's pressure readings meet specific criteria from a recent test.I've been on a stable heart or lung treatment for at least 6 weeks.I do not have significant heart disease affecting the left side of my heart.I have pulmonary hypertension but not from the heart's left side.
Research Study Groups:
This trial has the following groups:- Group 1: LTP001
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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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