Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.

• Conditions: YHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)

• Registration Number: EUCTR2004-003236-59-IE
• Lead Sponsor: ung Rx Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-06
• Last Update Posted: 24 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

Clinically stable male or female patients of any racial origin with severe PAH (NYHA Class III or Class IV), 18 to 75 years of age, can do an un-encouraged 6 minute walk test of between 200 and 400 meters with following conditions.
Cardiac catheterization within the past 12 months consistent with PAH, specifically PAPm ?25 mmHg (at rest), PCWP (or left ventricular end diastolic pressure) ?15 mmHg, and PVR >3 mmHg/L/min. Within the past 12 months patients must have had a chest radiograph consistent with the diagnosis of PAH. Able to understand and willing to sign the Informed Consent Form.
Have been on a stable course of 125 mg of Bosentan bid for at least 3 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pulmonary venous hypertension, PVOD or PCH, or severe COPD, any acute concomitant disease; Pregnancy/ lactation; change or discontinued any PAH medication within the last 3 months; received within the 30 days before trial or scheduled to receive any prostanoid, phosphodiesterase inhibitor (PDEI), or any investigational medication; hemorrhage; intolerance to any drug, especially to treprostinil sodium or prostanoids; new type of chronic therapy (e.g., a different category of vasodilator, diuretic) for PAH added within the last month, excepting anticoagulants; preexisting disease known to cause pulmonary hypertension (e.g., obstructive lung disease, parasitic disease affecting the pulmonary system, sickle cell anemia, mitral valve stenosis, portal hypertension); musculoskeletal disease or any other disease that would limit ambulation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified