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Unknown

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

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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 5, 13 and 25
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 5, 13 and 25 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline right heard catheterization Pulmonary vascular resistance (PVR) at week 25
Secondary study objectives
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 more

Trial 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

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,916 Previous Clinical Trials
4,253,838 Total Patients Enrolled
11 Trials studying Pulmonary Arterial Hypertension
750 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

LTP001 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05135000 — Phase 2
Pulmonary Arterial Hypertension Research Study Groups: LTP001, Placebo
Pulmonary Arterial Hypertension Clinical Trial 2023: LTP001 Highlights & Side Effects. Trial Name: NCT05135000 — Phase 2
LTP001 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05135000 — Phase 2
~14 spots leftby Dec 2025
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