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Prostacyclin Analogue

LTP001 for Pulmonary Arterial Hypertension

Phase 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 26, week 52

Awards & highlights

Study Summary

This trial is being done to see if a drug called LTP001 is safe and effective over a long period of time for people with pulmonary arterial hypertension (PAH). People who were part of a

Who is the study for?

This trial is for people with pulmonary arterial hypertension (PAH) who finished the initial CLTP001A12201 study without issues. They must be willing to follow the study plan and visits, have not failed previous treatments, and in the investigator's view, could benefit from LTP001.Check my eligibility

What is being tested?

The trial tests long-term safety and effectiveness of LTP001 in PAH patients. It continues treatment for those who completed a prior related study, regardless of whether they previously received LTP001 or not.See study design

What are the potential side effects?

Specific side effects are not listed here but generally include any adverse reactions participants experience during their extended use of LTP001 as observed by investigators.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 26, week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 26, week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 26, week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients with AEs and SAEs

Secondary outcome measures

Change from baseline in Cardiac Output (CO) pressures at week 26

Change from baseline in Fractional Area Change (FAC) pressures

Change from baseline in N-terminal fragment of the prohormone B-type natriuretic peptide (NT-ProBNP)

+12 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: LTP001Experimental Treatment1 Intervention

Participants will receive LTP001 orally once daily in the morning for approximately 52 weeks

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,859 Previous Clinical Trials

4,198,204 Total Patients Enrolled

10 Trials studying Pulmonary Arterial Hypertension

534 Patients Enrolled for Pulmonary Arterial Hypertension

Frequently Asked Questions

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

Is this medical study currently open for enrollment?

"Indeed, as documented on clinicaltrials.gov, this study is presently seeking suitable candidates. The initial posting of the trial occurred on March 27th, 2023, and it underwent its most recent revision on January 21st, 2024."

Answered by AI

Has the FDA granted approval to LTP001 for medical use?

"Based on our assessment, the safety rating for LTP001 is a 2. This evaluation corresponds to the nature of the trial being in Phase 2, where there exists some data demonstrating safety but no evidence yet supporting efficacy."

Answered by AI

Are there numerous medical facilities in the United States that are conducting this specific clinical trial?

"At present, this clinical trial is accepting patient enrollment at 11 diverse locations. These sites include Krakow, Wroclaw, Malaga and an additional 11 undisclosed places. To minimize travel requirements for participants who choose to enroll, it would be advantageous to select the clinic closest to their location."

Answered by AI

How many individuals are enrolled as participants in this ongoing medical study?

"Indeed, the information obtained from clinicaltrials.gov reveals that this ongoing clinical trial is actively seeking eligible participants. The initial posting of the trial occurred on March 27th, 2023 and it was most recently updated on January 21st, 2024. Recruitment aims to enroll a total of 40 individuals who will be distributed among 11 different research sites."

Answered by AI