Loading clinical trials...

Study of ACT-293987 (NS-304) in Pulmonary Arterial Hypertension (PAH) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of ACT-293987 (NS-304) in Pulmonary Arterial Hypertension (PAH)

A Multi-centre, Multinational, Open-label, Single-dose Acute Hemodynamic Study Followed by Multi-centre, Multinational, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy (Proof-of-concept) of ACT-293987 (NS-304) in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over

NCT00993408•Actelion

View on ClinicalTrials.gov

Summary

This is a multi-centre, multinational, open-label, single-dose acute hemodynamic study followed by randomized, double-blind, parallel-group, placebo controlled study. Eligible subjects will undergo an open-label, single-dose acute hemodynamic study with ACT-293987(NS-304) and 21 weeks of double-blind treatment during which subjects will receive either ACT-293987 (NS-304) or placebo b.i.d. Subjects who have completed the double-blind study can enter the open extension study (separate protocol) and receive administration of ACT-293987 (NS-304) if the subject wishes and the Investigator considers it appropriate.

Detailed Description

This is a multi-centre, multinational, open-label, single-dose acute hemodynamic study followed by a randomized, double-blind, parallel-group, placebo controlled study. Eligible subjects will undergo screening followed by randomized allocation to treatment group for the double-blind study, followed in turn by immediate enrollment in an open-label, single-dose acute hemodynamic study with ACT-293987 (NS-304) and 21 weeks of double-blind treatment during which subjects will receive either ACT-293987 (NS-304)or placebo twice daily (b.i.d.). Subjects who have completed the double-blind study can enter the open extension study and receive administration of ACT-293987 (NS-304) (separate protocol)if the subject wishes and the investigator considers it appropriate. Unblinding will occur on a subject-by-subject basis when the Week 17 data for the subject have been fixed. Approximately 44 subjects are to be randomized in a ratio of 3:1 to the two treatment groups, ACT-293987 (NS-304) and placebo (33 subjects to ACT-293987 (NS-304) and 11 subjects to placebo). Subjects will be randomized to the study following screening.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and female subjects 18 years of age or older with symptomatic PAH despite treatment with anticoagulants, calcium channel blockers, diuretics, cardiac glycosides, supplemental oxygen, endothelin-receptor antagonists and/or phosphodiesterase inhibitors. Endothelin receptor antagonists and phosphodiesterase inhibitors must have been used at a stable dose for more than 12 weeks before screening.
•2. Subjects with idiopathic PAH, familial pulmonary arterial hypertension and PAH associated with collagen vascular disease, corrected congenital vitium (congenital systemic to pulmonary shunts surgically repaired at least five years before) or anorexigen use.
•3. Diagnosis of PAH established according to the standard criteria:
•1. Resting mean pulmonary arterial pressure \> 25 mmHg.
•2. PVR \> 240 dynes s/cm5.
•3. Pulmonary capillary wedge pressure or left ventricular end diastolic pressure \< 15 mmHg.
•4. PVR \> 400 dynes s/cm5.
•5. Two 6MWTs between 150 and 500 m (inclusive) with the variation in 6MWT within ± 15% between the two tests despite other treatments for PAH.
•\- Two 6MWT values are needed. Only one 6MWT should be performed at screening for confirmation of eligibility if 6MWT has been previously conducted within six weeks of the screening visit unless the subject was taking another investigational drug or participating in a specific training and exercise programme at the time of the previous test.
•6. Subjects who are able and willing to refrain from sunbathing, prolonged sun exposure, and solarium use, and to limit skin and eye exposure to sunlight using appropriate precautions (protective clothing, sunscreen and sunglasses) from the first dose until 14 days after study drug discontinuation.

Exclusion Criteria

•Subjects will not be entered in the study for any of the following reasons:
•1. Subjects with clinically unstable right heart failure within the last three months (NYHA Class IV).
•2. Subjects who have received or have been scheduled to receive long-term treatment with epoprostenol within three months before screening.
•3. Hypotensive subjects (systemic systolic blood pressure \< 85 mmHg).
•4. Subjects with PAH associated with portal hypertension, Human Immunodeficiency Virus infection or unrepaired congenital systemic to pulmonary shunts.
•5. Subjects with ventilation-perfusion lung scan or pulmonary angiography indicative of thromboembolic disease.
•6. Subjects with significant obstructive (forced expiratory volume in one second \[FEV1\]/forced vital capacity \[FVC\] \< 70% predicted) or restrictive (total lung capacity \< 70% predicted) lung disease.
•7. In collagen vascular diseases, subjects with significant interstitial disease (FVC \< 70% predicted).
•8. Subjects with evidence of left sided heart disease.
•9. Subjects with moderate or severe hepatic impairment (Child-Pugh B and C).
+4 more criteria

Locations (8)

Medizinische Universitat Wien, Universitatsklinik fur Innere Medizin II, Kardiologie

Vienna, Austria

Gasthuisberg University Hospital, Pneumology

Leuven, Belgium

Hopital Antoine Beclere, Pneumologie

Paris, France

Department of Respiratory Medicine, Hannover Medical School

Hanover, Germany

Semmelweis University, Clinic of Pulmonology

Budapest, Hungary

Hospital Sant'Orsola Malpighi, Cardiology's Department

Bologna, Italy

Instytut Gruzilcy i Chorob Pluc, Klinika Chorob Wewnetrznych Klatki Piersiowej

Warsaw, Poland

Hammersmith Hospital

London, United Kingdom

Key Dates

Start Date

April 30, 2008

Primary Completion Date

June 30, 2009

Completion Date

June 30, 2009

Last Updated

September 12, 2025

Enrollment

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension

Interventions

ACT-293987 (NS-304)

DEVICE

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

NCT06649110

Healthy Volunteers, Pulmonary Arterial Hypertension

View study

RECRUITINGPHASE3

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

NCT07218029

Pulmonary Arterial Hypertension

View study

RECRUITINGPHASE1

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of ACT-293987 (NS-304) in Pulmonary Arterial Hypertension (PAH)

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

COMPERA / COMPERA-KIDS

The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization