Investigación clínica doble ciego controlada con placebo sobre la efficacia y la tolerabilidad de Treprostinil sódico inhaldo en pacientes con Hipertensión Pulmonar Graves.Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.
- Conditions
- Hipertensión Arterial Pulmonar Grave de clase III y IV de la NYHANYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH)
- Registration Number
- EUCTR2004-003236-59-ES
- Lead Sponsor
- nited Therapeutics Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
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 metres 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
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 the trial or scheduled to receive any prostanoid, PDE5 inhibitors other than sildenafil or any investigational medication; haemorrhage; intolerance to any drug, especially to treprostinil sodium or prostanoids; new type of chronic therapy (e.g. a different catergory of vasodilator, diuretic) for PAH added within the last month, expecting anticoagulants; preexisiting disease known to cause pulmonary hypertension (e.g. obstructuve lung disease, parasitic disease affecting the pulmonary system, sickle cell anaemia, 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method