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Rapid Switch From Flolan to Remodulin in the Outpatient Clinic

Information source: United Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension, Pulmonary

Intervention: treprostinil sodium (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: United Therapeutics

Official(s) and/or principal investigator(s):
Victor Tapson, MD, Principal Investigator, Affiliation: Duke University Health System

Summary

The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.

Clinical Details

Official title: Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin« (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension in the Outpatient Clinic: Safety, Efficacy and Treatment Satisfaction

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Six Minute Walk Distance

Secondary outcome:

Change in WHO Functional Classification

Change in Borg Dyspnea Score Immediately After Six Minute Walk

Change in Score on Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)

Change in Score on Treatment Satisfaction Questionnaire for Medication

Change in Total Weekly Time Spent With the Specific Activities Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol

Change in PAH Signs and Symptoms- Fatigue

Change From in Signs and Symptoms of PAH- Edema

Change in Signs and Symptoms of PAH- Dyspnea

Change in Signs and Symptoms of PAH- Orthopnea

Change in Signs and Symptoms of PAH- Dizziness

Change in Signs and Symptoms of PAH- Syncope

Change in Signs and Symptoms of PAH- Chest Pain

Patient Impression of Change Questionnaire

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 health related quality of life (HRQOL). Remodulin® (treprostinil sodium), a stable analogue of prostacyclin, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo. Recently, Remodulin received FDA approval for intravenous therapy based upon bioequivalence of the IV and SC routes of administration. Remodulin is more chemically stable than epoprostenol and may offer potential safety and convenience advantages compared to intravenous epoprostenol that may impact Health Related Quality of Life (HRQOL) and/or patient satisfaction. Unlike epoprostenol, Remodulin does not need to be mixed daily and is stable at room temperature eliminating the need for ice packs. Furthermore, since Remodulin remains in the body longer than epoprostenol (4 hrs instead of less than 5 minutes) there is less risk of cardiovascular collapse from a sudden interruption of infusion, such as a line clog. In an open-label study in Europe, patients who were using a type of portable medication pump called the CADD Legacy pump were rapidly switched from Flolan to Remodulin with no serious side effects. This study will examine effects of switching from therapy with epoprostenol or Flolan to IV Remodulin and compare changes in HRQOL and treatment satisfaction before and after rapid switch from epoprostenol to Remodulin in patients with pulmonary hypertension using the CADD legacy pump.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Be between 18 years and 70 years of age

- Be male or if female, be physiologically incapable of childbearing or practicing an

acceptable method of birth control (women of childbearing potential must have a negative pregnancy test).

- Have a current World Health Organization (WHO) functional classification of II-III

status

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

Group 1 pulmonary arterial hypertension (IPAH, FPAH, APAH);Group 3 pulmonary hypertension associated with lung disease (Mild interstitial lung disease associated with predominant features of right heart failure as seen in Group 1 PAH patients); Group 4 pulmonary hypertension due to chronic thromboembolic pulmonary hypertension (CTEPH)

- In the opinion of the investigator, be hemodynamically stable with no signs or

symptoms of disease progression

- Be receiving intravenous epoprostenol therapy for at least three months and a stable

dose for at least one month prior to Baseline.

- Have a central intravenous catheter in place.

- Have a baseline six-minute walk distance of at least 150 meters.

- Be optimally treated with conventional pulmonary hypertension therapy and clinically

stable for at least one month prior to baseline assessments.

- Be mentally and physically capable of learning to administer Remodulin using an

intravenous infusion pump. Exclusion Criteria:

- Be a nursing or pregnant woman

- Have had 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.

- Have any PAH medication discontinued within the week prior to study entry.

- Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3

months.

- Have an on-going central venous line infection within the past 30 days.

- Have evidence of predominant left-sided heart disease

- Have any other disease that is associated with pulmonary hypertension (e. g. sickle

cell anemia, schistosomiasis).

- Have 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.

- Have uncontrolled systemic hypertension as evidenced by a systolic blood pressure

greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg.

- Be receiving an investigational drug, have in place an investigational device, or

have participated in an investigational drug study within the past 30 days.

- Have the presence of any physiological or psychological condition that

contraindicates the administration of Remodulin.

Locations and Contacts

Duke University Medical Center, Durham, North Carolina 27705, United States
Additional Information

Starting date: March 2008
Last updated: June 19, 2013

Page last updated: August 23, 2015

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