Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458042
Status:
TERMINATED
Last Update Posted:
2007-11-12
First Post:
2007-04-05
Brief Title:
Transitioning To IV Remodulin From Ventavis in Patients With PAH Safety Efficacy and Treatment Satisfaction
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
Transitioning To Intravenous Remodulin Treprostinil Sodium From Inhaled Iloprost Ventavis in Patients With Pulmonary Arterial Hypertension Safety Efficacy and Treatment Satisfaction
Status:
TERMINATED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low Enrollment
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 study is to compare the effects of switching from inhaled Ventavis to intravenous Remodulin in PAH patients who are considered to be failing inhaled Ventavis therapy This study is intended to provide information on the safe transition from Ventavis to Remodulin as well as the impact intravenous Remodulin may have on overall quality of life and treatment satisfaction compared to Ventavis
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 quality of life QOL
Remodulin treprostinil sodium a prostacyclin analog possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo Remodulin is an approved pharmacotherapy for PAH delivered as either a continuous subcutaneous infusion or intravenous infusion Ventavis iloprostis an inhaled prostacyclin analogue with similar properties to Remodulin In December 2004 Ventavis was approved for use in the United States by the FDA for the treatment of pulmonary arterial hypertension WHO Group I for patients with NYHA III or IV symptoms
As the PAH community gains experience with the use of inhaled Ventavis questions have arisen as to how to transition a patient on inhaled Ventavis to Remodulin in the presence of worsening symptoms or at a patients request related to dissatisfaction with the frequency of daily treatments This study will examine effects of switching from Ventavis to IV Remodulin and compare changes in exercise capacity safety HRQOL and treatment satisfactions
Participation will last up to 12 weeks Study procedures include routine blood tests medical history physical exams disease evaluation exercise tests and patient questionnaires Participates will have 4 clinic visits during the study and will spend at least one night in the hospital
Remodulin treprostinil sodium a prostacyclin analog possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo Remodulin is an approved pharmacotherapy for PAH delivered as either a continuous subcutaneous infusion or intravenous infusion Ventavis iloprostis an inhaled prostacyclin analogue with similar properties to Remodulin In December 2004 Ventavis was approved for use in the United States by the FDA for the treatment of pulmonary arterial hypertension WHO Group I for patients with NYHA III or IV symptoms
As the PAH community gains experience with the use of inhaled Ventavis questions have arisen as to how to transition a patient on inhaled Ventavis to Remodulin in the presence of worsening symptoms or at a patients request related to dissatisfaction with the frequency of daily treatments This study will examine effects of switching from Ventavis to IV Remodulin and compare changes in exercise capacity safety HRQOL and treatment satisfactions
Participation will last up to 12 weeks Study procedures include routine blood tests medical history physical exams disease evaluation exercise tests and patient questionnaires Participates will have 4 clinic visits during the study and will spend at least one 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