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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 5, 13 and 25
Awards & highlights

Study Summary

This trial tests if a drug (LTP001) is safe and effective for treating pulmonary arterial hypertension (PAH).

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.Check my eligibility
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.See study design
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.

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

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 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
2,866 Previous Clinical Trials
4,199,279 Total Patients Enrolled
10 Trials studying Pulmonary Arterial Hypertension
527 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
~16 spots leftby Jun 2025
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