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-DE

Lead Sponsor: nited Therapeutics Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 220

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 450 meters with following conditions.
Previous cardiac catheterisation consistent with PAH, specifically PAPm greater than or equal to 25 mmHg (at rest), PCWP (or left ventricular end diastolic pressure) less than or equal to 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 or a stable dose of sildenafil 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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pulmonary venous hypertension, (PVOD), pulmonary capillary haemangiomatosis (PCH), severe COPD, congenital pulmonary hypertension or chronic thromboembolic pulmonary hypertension or any acute concomitant disease; Cogenital heart defect or cogenital heart 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, PDE5 inhibitors other than sildenafil 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.