NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)
Conditions
Interventions
Product Name: Treprostinil Sodium Solution for Inhalation
Product Code: N/A
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: N/A
Sponsors
United Therapeutics Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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 catheterization 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effects of chronically administered, inhaled Treprostinil Sodium (TRE) on exercise capacity with an un-encouraged 6-minute walk test (6MWT) in patients with pulmonary arterial hypertension (PAH). ; Secondary Objective: (1) To assess the safety and tolerability of chronically administered TRE, (2) To assess the effects of chronically administered TRE on the signs and symptoms of PAH, (3) To assess the effects of chronically administered TRE on NYHA Functional Class, and (4) To assess the effect of TRE on troponin and Pro-BNP levels. ; Primary end point(s): Measure of efficacy will be improvement in exercise capacity as defined by the maximum distance a patient can walk in a peak unencouraged six minute walk test (6MWT) at 12 weeks when compared to baseline. A peak 6MWT is defined as a walk no less than ten minutes and no more than 60 minutes post study drug inhalation. Additional analyses of the primary measure will be done on the 6MWT performed immediately following the first dose of study drug at Visit 2, and on the trough 6MWT results. A trough 6MWT is defined as a walk prior to or no less than 4 hours post study drug inhalation. | — |
Countries
Austria, Belgium, Germany, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed