Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: United Therapeutics
• Treatments: Treprostinil

Criteria

Inclusion Criteria:

• Age 18 to 65 years

• Diagnosis of one of the following WHO Classifications of pulmonary hypertension:

1. Group 1 pulmonary arterial hypertension

• Idiopathic pulmonary arterial hypertension (IPAH)

• Familial pulmonary arterial hypertension (FPAH)

• Associated pulmonary arterial hypertension (APAH):

1. collagen vascular disease

2. congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry.

3. portal hypertension

4. drugs and toxins

2. 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 Criteria:

• 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):

1. Total Lung Capacity ≤ 60% (predicted) or

2. 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.