Status:
TERMINATED
Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction
Lead Sponsor:
United Therapeutics
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
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 dis...
Eligibility Criteria
Inclusion
- Be between 18 years and 65 years of age
- WHO Class II-III
- Diagnosis of one of the following Group I WHO clinical classifications: Idiopathic or familial pulmonary arterial hypertension (PAH) or PAH associated with a collagen vascular disease or PAH associated with congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry or PAH associated with portal hypertension with mild or moderate hepatic dysfunction or PAH associated with drugs or toxins.
- Receiving inhaled iloprost for at least two months prior to screening or prior to treatment discontinuation.
- May have discontinued iloprost treatment against medical advice up to thirty days prior to screening
- Be mentally and physically capable of learning to administer Remodulin using an intravenous infusion pump.
Exclusion
- Be a nursing or pregnant woman
- Have any PAH medication, other than inhaled iloprost, discontinued within the week prior to study entry.
- Received any prostacyclin or prostacyclin analog except iloprost in the past 3 months.
- Previous history of significant parenchymal lung disease
- Have any other type of PAH including but not limited to PAH related to thrombotic or embolic disease
- Have evidence of left-sided heart disease
- Musculoskeletal disorder (e.g. arthritis, artificial leg, etc.) or any other disease, which is thought to limit ambulation, or be connected to a machine, which is not portable.
- Uncontrolled systemic hypertension or chronic renal insufficiency
- Use of an investigational drug within the past 30 days.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00458042
Start Date
March 1 2007
End Date
November 1 2007
Last Update
November 12 2007
Active Locations (2)
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1
UCSD Medical Center Thornton Hospital
La Jolla, California, United States, 92037
2
UCSD Medical Center Hillcrest Campus
San Diego, California, United States, 92103