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Sponsored by: |
United Therapeutics |
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Information provided by: | United Therapeutics |
ClinicalTrials.gov Identifier: | NCT00458042 |
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.
Condition | Intervention | Phase |
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Hypertension, Pulmonary |
Drug: treprostinil sodium |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Transitioning To Intravenous Remodulin® (Treprostinil Sodium) From Inhaled Iloprost (Ventavis®) in Patients With Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction |
Estimated Enrollment: | 10 |
Study Start Date: | March 2007 |
Study Completion Date: | November 2007 |
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 (iloprost)is 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 patient's 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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCSD Medical Center Thornton Hospital | |
La Jolla, California, United States, 92037 | |
UCSD Medical Center Hillcrest Campus | |
San Diego, California, United States, 92103 |
Principal Investigator: | Hyong (Nick) Kim, MD | UCSD Medical Center |
Study ID Numbers: | RIV-PH-412 |
Study First Received: | April 5, 2007 |
Last Updated: | November 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00458042 History of Changes |
Health Authority: | United States: Institutional Review Board |
Ventavis iloporst Remodulin |
treprostinil PAH prostacyclin |
Vasodilator Agents Vascular Diseases Treprostinil Cardiovascular Agents Antihypertensive Agents Iloprost Respiratory Tract Diseases |
Hypertension, Pulmonary Lung Diseases Idiopathic Pulmonary Hypertension Epoprostenol Platelet Aggregation Inhibitors Hypertension |
Vasodilator Agents Hematologic Agents Vascular Diseases Treprostinil Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Iloprost |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Therapeutic Uses Cardiovascular Diseases Platelet Aggregation Inhibitors Hypertension |