Status:
TERMINATED
Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH
Lead Sponsor:
United Therapeutics
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 a...
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
- Age 18 to 65 years
- Diagnosis of one of the following WHO Classifications of pulmonary hypertension:
- Group 1 pulmonary arterial hypertension
- Idiopathic pulmonary arterial hypertension (IPAH)
- Familial pulmonary arterial hypertension (FPAH)
- Associated pulmonary arterial hypertension (APAH):
- collagen vascular disease
- congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry.
- portal hypertension
- drugs and toxins
- Group 4 pulmonary hypertension due to chronic thromboembolic pulmonary hypertension (CTEPH)
- WHO Class II-III
- Currently receiving intravenous epoprostenol therapy for at least three months and a stable dose for at least one month.
- Have central intravenous catheter
- Optimally treated with conventional pulmonary hypertension therapy and clinically stable for at least one month.
- Mentally and physically capable of learning to administer Remodulin using an intravenous infusion pump.
Exclusion
- nursing or pregnant woman
- received a new type of chronic therapy (including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil) for pulmonary hypertension added within the last month.
- Had any PAH medication discontinued within the week prior to study entry.
- Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
- Had a central venous line infection within the past 30 days.
- Previous documented evidence of significant parenchymal lung disease as evidenced by pulmonary function tests as follows (any one of the following):
- Total Lung Capacity ≤ 60% (predicted) or
- If Total Lung Capacity is between 60% and 70% (predicted), a High Resolution Computed Tomography (CT) scan must be performed to rule out diffuse interstitial fibrosis or alveolitis
- History of or evidence of left-sided heart disease
- Having any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis).
- Having a 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 as evidenced by a systolic blood pressure greater than 160 millimeters of mercury (mmHg) or diastolic blood pressure greater than 100 mmHg.
- Chronic renal insufficiency as defined by serum creatinine greater than 2.5 milligrams per deciliter (mg/dL) or the requirement for dialysis.
- Receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.
- Active infection, or any other ongoing condition that would interfere with the interpretation of study assessments.
- The presence of any physiological or psychological condition that contraindicates the administration of Remodulin.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00439946
Start Date
February 1 2007
End Date
March 1 2011
Last Update
January 3 2024
Active Locations (3)
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1
University of California San Francisco (UCSF) Medical Center
San Francisco, California, United States, 94143
2
THE NEW YORK-PRESBYTERIAN HOSPITAL Weill Cornell Medical Center
New York, New York, United States, 10065
3
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73122