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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
History of PAH belonging to one of the following subgroups of the Clinical Classification Group 1 (WHO): participants with idiopathic pulmonary arterial hypertension (IPAH), Hereditary pulmonary arterial hypertension, Congenital heart disease (surgically repaired at least 12 months prior to screening), drug or toxin induced (for example, anorexigen, or methamphetamine use)
Pulmonary Vascular Resistance > 6 Wood units (480 dynes s/cm-5), as determined by right heart catheterization within 20 days of randomization
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
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I have a specific type of high blood pressure in the lungs related to genetics, heart defects, or certain drug use.
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My heart test shows high pressure in the lungs' blood vessels.
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I can walk between 150 and 550 meters in 6 minutes.
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My heart's pressure readings meet specific criteria from a recent test.
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I've been on a stable heart or lung treatment for at least 6 weeks.

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
2,851 Previous Clinical Trials
4,197,542 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still enrollment opportunities available for individuals interested in this research?

"Affirmative, clinicaltrials.gov lists this trial as currently accepting patients. Initially posted on June 30th 2022 and last revised April 17th 2023; the research is now enrolling 44 individuals across 12 locations."

Answered by AI

What health risks could be incurred by taking LTP001?

"Our team at Power assigned LTP001 a rating of 2 on the safety scale, as there is limited data indicating its efficacy yet more substantial evidence suggesting that it may be safe."

Answered by AI

Is this research endeavor including participants aged seventy and older?

"This trial is open to participants aged between 18 and 75. For those below the age of consent, there are 53 trials available while 664 exist for seniors above 65 years old."

Answered by AI

Am I eligible to take part in this clinical experiment?

"To successfully be accepted for this trial, aspirants must suffer from pulmonary arterial hypertension and fall into the age bracket of 18 to 75. The total number of participants being sought is 44."

Answered by AI

What is the maximum amount of participants who can enroll in this trial?

"Affirmative. The details on clinicaltrials.gov suggest that this study is still welcoming participants, having originally been posted at the end of June 2022 and recently updated in mid-April 2023. Forty four patients need to be enrolled from 12 sites."

Answered by AI

In what capacity are hospitals participating in this research initiative?

"As of now, recruitment for this study is taking place in 12 different medical centres spread across Caba, Santander and Barcelona. To minimize the need to travel far distances, it may be beneficial to choose a clinic close-by when considering enrollment into this trial."

Answered by AI
~0 spots leftby Apr 2024