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NCT05764265 · ClinicalTrials.gov registry record · Phase 2

Extension Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension Participants

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Terminated
Registry status
Phase 2
Development phase
31
Enrollment target

NCT05764265: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.

NCT05764265 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05764265, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.

TERMINATED
Registry status
Phase 2
Development phase
31 participants
Enrollment target

Study Summary

The purpose of this study was to measure the long-term safety and efficacy profile of LTP001 in participants with pulmonary arterial hypertension (PAH). The study offered participants who had completed the CLTP001A12201 double-blind parent study in PAH an opportunity to receive LTP001 (whether they were on LTP001 or not). Unblinding of the treatment received in CLTP001A12201 was generally not needed but could occur on request by the investigator.

Primary Outcome

Incidence and severity of adverse events (AEs) by treatment group, including changes in the vital signs, electrocardiogram and laboratory results qualifying and reported as AEs. Due to the study termination, no patient reached Week 52. At the end of treatment visit, final safety assessments were performed.

Interventions

  • DRUG LTP001

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2023-03-27
Est. Completion 2024-05-14
Phase Phase 2
Novartis Pharmaceuticals

1,375 total trials

Why NCT05764265 stopped before completion

NCT05764265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which LTP001 is the first listed.

NCT05764265 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05764265 about?

NCT05764265 is a clinical study titled "Extension Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension Participants". The purpose of this study was to measure the long-term safety and efficacy profile of LTP001 in participants with pulmonary arterial hypertension (PAH). The study offered participants who had completed the CLTP001A12201 double-blind parent study in PAH an opportunity to receive LTP001 (whether they ...

What is the current status of trial NCT05764265?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2023-03-27. Estimated completion is 2024-05-14.

What interventions are being tested in trial NCT05764265?

The interventions under investigation include: LTP001 (DRUG).

Who is sponsoring clinical trial NCT05764265?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05764265's enrollment target sits among peer trials

31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05764265, the US trial registry maintained by the National Library of Medicine. NCT05764265 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.