Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00439946
Status:
TERMINATED
Last Update Posted:
2024-01-03
First Post:
2007-02-22
Brief Title:
Safety Efficacy and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin Treprostinil Sodium Using the Crono Five Ambulatory Infusion Pump in Patients With Stable Pulmonary Arterial Hypertension PAH Safety Efficacy and Treatment Satisfaction
Status:
TERMINATED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed due to limited availability of eligible subjects and competition by for enrollment by other studies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this 8-week study is to compare the effects of switching from intravenous Flolan to intravenous Remodulin therapy Remodulin treprostinil sodium is an approved therapy for pulmonary arterial hypertension PAH Unlike Flolan Remodulin does not need to be mixed daily and is stable at room temperature so there is no need for ice packs In addition Remodulin is changed every 48hrs instead of every 12-24 with ice packs or every 8 hours without ice packs with Flolan Flolan is given using a type of portable medication pump called the CADD Legacy infusion pump In this study Remodulin will be given using a smaller and lighter medication pump called the Crono Five infusion pump This study will also assess the effect that changing to Remodulin will have on treatment satisfaction and patient quality of life
Detailed Description:
Pulmonary arterial hypertension PAH which is defined as an elevation in pulmonary arterial pressure and pulmonary vascular resistance is a severe hemodynamic abnormality common to a variety of diseases and syndromes Elevation in pulmonary arterial pressure causes an increase in right ventricular afterload impairing right ventricular function and ultimately leading to inactivity and death The goal of PAH treatment is to lengthen survival time to ameliorate symptoms of PAH and to improve health related quality of life HRQOL
Remodulin treprostinil sodium a stable analogue of prostacyclin possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo Recently Remodulin received FDA approval for intravenous therapy based upon bioequivalence of the intravenous IV and subcutaneous SC routes of administration Remodulin is more chemically stable than epoprostenol and may offer potential safety and convenience advantages compared to intravenous epoprostenol that may impact Health Related Quality of Life HRQOL andor patient satisfaction Unlike epoprostenol Remodulin does not need to be mixed daily and is stable at room temperature eliminating the need for ice packs Since Remodulin remains in the body longer than epoprostenol 4 hrs instead of less than 5 minutes there is less risk of cardiovascular collapse from a sudden interruption of infusion such as a line clog In an open-label study in Europe patients who were using a type of portable medication pump called the CADD Legacy pump were rapidly switched from Flolan to Remodulin with no serious side effects This study will examine effects of switching from therapy with epoprostenol or Flolan to IV Remodulin and compare changes in HRQOL and treatment satisfaction before and after rapid switch from epoprostenol to Remodulin in patients with pulmonary hypertension from the CADD legacy pump to a smaller pump called the Crono Five
Participation in this study will last approximately 10 weeks Study procedures include routine blood tests medical history physical exams disease evaluation exercise tests and patient questionnaires Participants will have 4 visits during the study and will spend at least 1 night in the hospital
Remodulin treprostinil sodium a stable analogue of prostacyclin possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo Recently Remodulin received FDA approval for intravenous therapy based upon bioequivalence of the intravenous IV and subcutaneous SC routes of administration Remodulin is more chemically stable than epoprostenol and may offer potential safety and convenience advantages compared to intravenous epoprostenol that may impact Health Related Quality of Life HRQOL andor patient satisfaction Unlike epoprostenol Remodulin does not need to be mixed daily and is stable at room temperature eliminating the need for ice packs Since Remodulin remains in the body longer than epoprostenol 4 hrs instead of less than 5 minutes there is less risk of cardiovascular collapse from a sudden interruption of infusion such as a line clog In an open-label study in Europe patients who were using a type of portable medication pump called the CADD Legacy pump were rapidly switched from Flolan to Remodulin with no serious side effects This study will examine effects of switching from therapy with epoprostenol or Flolan to IV Remodulin and compare changes in HRQOL and treatment satisfaction before and after rapid switch from epoprostenol to Remodulin in patients with pulmonary hypertension from the CADD legacy pump to a smaller pump called the Crono Five
Participation in this study will last approximately 10 weeks Study procedures include routine blood tests medical history physical exams disease evaluation exercise tests and patient questionnaires Participants will have 4 visits during the study and will spend at least 1 night in the hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None