Status:
COMPLETED
Study of ACT-293987 (NS-304) in Pulmonary Arterial Hypertension (PAH)
Lead Sponsor:
Actelion
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Diagnosis of PAH established according to the standard criteria:
- Resting mean pulmonary arterial pressure \> 25 mmHg.
- PVR \> 240 dynes s/cm5.
- Pulmonary capillary wedge pressure or left ventricular end diastolic pressure \< 15 mmHg.
- PVR \> 400 dynes s/cm5.
- 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.
- 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
- Subjects will not be entered in the study for any of the following reasons:
- Subjects with clinically unstable right heart failure within the last three months (NYHA Class IV).
- Subjects who have received or have been scheduled to receive long-term treatment with epoprostenol within three months before screening.
- Hypotensive subjects (systemic systolic blood pressure \< 85 mmHg).
- Subjects with PAH associated with portal hypertension, Human Immunodeficiency Virus infection or unrepaired congenital systemic to pulmonary shunts.
- Subjects with ventilation-perfusion lung scan or pulmonary angiography indicative of thromboembolic disease.
- 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.
- In collagen vascular diseases, subjects with significant interstitial disease (FVC \< 70% predicted).
- Subjects with evidence of left sided heart disease.
- Subjects with moderate or severe hepatic impairment (Child-Pugh B and C).
- Subjects with clinically significant chronic renal insufficiency (estimated creatinine clearance \< 30 mL/minute, or serum creatinine \> 2.5 mg/dL).
- Subjects who are receiving or have been receiving any investigational drugs within 30 days before screening.
- Subjects with musculoskeletal disorder limiting ambulation.
- Females who are breast-feeding, pregnant or plan to become pregnant during the study and females who are not using a highly effective method of birth control (failure rate less than 1% per year) such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner.
Key Trial Info
Start Date :
April 30 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2009
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00993408
Start Date
April 30 2008
End Date
June 30 2009
Last Update
September 12 2025
Active Locations (8)
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1
Medizinische Universitat Wien, Universitatsklinik fur Innere Medizin II, Kardiologie
Vienna, Austria, 1090
2
Gasthuisberg University Hospital, Pneumology
Leuven, Belgium, 3000
3
Hopital Antoine Beclere, Pneumologie
Paris, France
4
Department of Respiratory Medicine, Hannover Medical School
Hanover, Germany, 30625