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Experimental PAH drug trial halted early

NCT ID NCT05135000

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called LTP001 in 47 people with pulmonary arterial hypertension (PAH), a condition where high blood pressure damages the arteries in the lungs. The goal was to see if LTP001 could improve blood flow and exercise ability. However, the trial was terminated early, meaning it likely did not show enough promise to continue.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LTP001 (an experimental oral drug)
What this could lead to
If it had worked, LTP001 could have pointed toward a new treatment option for pulmonary arterial hypertension, a serious lung condition.
What could go wrong
The trial was terminated early, meaning it likely did not show enough benefit or had safety concerns. It was also a small Phase 2 study, so results are very preliminary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

47 people

The number who actually took part.

Started

Jun 2022

Finished

Apr 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). * 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. * Pulmonary Vascular Resistance \> 6 Wood units (480 dynes s/cm-5), as determined by right heart catheterization within 20 days of randomization. * WHO Functional Class II-III * 6MWD must be between 150 and 550 m (inclusive). The qualifying test needs to be within 20 days of randomization. To meet the above criterion additional six minute walk test (6MWT) may be performed up to a maximum of 3 tests in total prior to dosing; the minimal time difference between two tests should be at least 4 h. * Standard of care therapy which is stable at least 6 weeks prior to RHC and qualifying 6MWT assessment within 20 days of randomization. Standard of care includes one or more of the following treatments: * prostacyclin analogues and receptor agonists (if I.V., dose adjustments must be within 20% of initial stable dose) * endothelin receptor antagonists (ERAs) * phosphodiesterase type 5 inhibitors (PDE5i) * soluble guanylate cyclase (sGC) stimulators Exclusion Criteria: * 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. * Participants with a history of left sided heart disease, chronic left sided heart failure, congenital or acquired valvular disease compromising left ventricular function and/or pulmonary venous hypertension or symptomatic coronary disease (non-symptomatic, revascularized coronary artery disease would be acceptable). * Participants with obstructive lung disease defined as: FEV1/FVC \< 60% and FEV1 \< 60% of predicted value after bronchodilator administration as well as participants with moderate or severe restrictive lung disease: Total Lung Capacity \< 70% of predicted value. Testing must have occurred within 24months of screening. If historical testing is not available, then lung function testing must be conducted during the screening period. * 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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Medical Univ of South Carolina

    Charleston, South Carolina, 29425, United States

  • Novartis Investigative Site

    Caba, Buenos Aires, C1025ABI, Argentina

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Dresden, 01307, Germany

  • Novartis Investigative Site

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    Amsterdam, 1081 HV, Netherlands

  • Novartis Investigative Site

    Krakow, 31 202, Poland

  • Novartis Investigative Site

    Lodz, 91-347, Poland

  • Novartis Investigative Site

    Wroclaw, 50-556, Poland

  • Novartis Investigative Site

    Málaga, Andalusia, 29010, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Sheffield, South Yorkshire, S10 2JF, United Kingdom

  • Novartis Investigative Site

    London, SW3 6PH, United Kingdom

  • Pulmonary Associates PA

    Mesa, Arizona, 85206, United States

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