A Single-arm Open Label Study Evaluating the Impact on Lifestyle of a New Thermo-stable Formulation of Flolan in Subjects with Pulmonary Arterial Hypertension (PAH) (FLR115332)
- Conditions
- pulmonary arterial hypertension10037454
- Registration Number
- NL-OMON35565
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
* 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.
* 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) <90% as measured by pulse oximetry at screening.
* Subjects have been hospitalized as an emergency or visited the emergency room for a condition related to PAH or treatment for PAH in the last 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>SF-36 (quality of life) questionnaire, ease of use (study-specific<br /><br>questionnaire), dose titration.</p><br>
- Secondary Outcome Measures
Name Time Method <p>E.g. 6 min walk test (distance, dyspnea), WHO class, adverse events, invasive<br /><br>hemodynamics (in case of standard right heart catheterization).</p><br>