pulmonary arterial hypertension
Conditions
Interventions
Treatment with the new Flolan formulation.
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Male and female subject 18-75 y of age, who are being treated for pulmonary arterial hypertension with a stable dose of commercially available Flolan for at least 3 months. * Subjects must be on stable doses of any other current PAH treatments. * Subjects must walk a distance of at least 150 meters during six-minute walk distance test (6MWD). This test must be completed during the Screening Visit. * Adequate contraception for females of childbearing potential. * Capable of giving informed consent.
Exclusion criteria
Exclusion criteria: * Subjects who are given FLOLAN for a condition or in a manner that is outside the approved indication. * Subjects with congestive heart failure arising from severe left ventricular dysfunction. * Subjects, with or without supplemental oxygen, who have a resting arterial oxygen saturation (SaO2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SF-36 (quality of life) questionnaire, ease of use (study-specific questionnaire), dose titration. | — |
Secondary
| Measure | Time frame |
|---|---|
| E.g. 6 min walk test (distance, dyspnea), WHO class, adverse events, invasive hemodynamics (in case of standard right heart catheterization). | — |
Countries
Netherlands
Outcome results
None listed