Phase 4 Completed N=10 Treatment

Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin

Source: ClinicalTrials.gov NCT00373360 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Jan 2013

Primary outcomePrimary: Change in the Distance Transversed During the 6 Minute Walk Test From Baseline to Week 8. — -2.2 meters — p=1.000

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Distance Transversed During the 6 Minute Walk Test From Baseline to Week 8.	-2.2	1.000
SECONDARY Change in Borg Dyspnea Score Immediately After Six Minute Walk Test From Baseline to Week 8	1.56	0.008 sig
SECONDARY Change in World Health Organization (WHO) Functional Classification of PAH From Baseline to Week 8	11; 89; 0	1.000
SECONDARY Change in Symptoms of Dyspnea From Baseline to Week 8	22; 33; 44	0.531
SECONDARY Change in Symptoms of Edema From Baseline to Week 8	22; 56; 22	1.000
SECONDARY Change in Symptoms of Orthopnea From Baseline to Week 8	22; 78; 0	0.500
SECONDARY Change in Symptoms of Dizziness From Baseline to Week 8	11; 89; 0	1.000
SECONDARY Change in Symptoms of Fatigue From Baseline to Week 8	22; 67; 11	1.000
SECONDARY Change in Symptoms of Syncope From Baseline to Week 8	0; 100; 0	—
SECONDARY Change in Symptoms of Chest Pain From Baseline to Week 8	0; 89; 11	1.000
SECONDARY Change in Effectiveness Score on Treatment Satisfaction Scale From Baseline to Week 8	71.6; 82.7	0.031 sig
SECONDARY Change in Side-Effects Score on Treatment Satisfaction Scale From Baseline to Week 8	71.5; 84.7	0.031 sig
SECONDARY Change in Convenience Score on Treatment Satisfaction Scale From Baseline to Week 8	59.9; 90.7	0.004 sig
SECONDARY Change in Global Satisfaction Score on Treatment Satisfaction Scale From Baseline to Week 8	84.1; 92.1	0.063
SECONDARY Change in Total Score on Quality of Life Questionnaire From Baseline to Week 8	18.9; 12.9	0.203
SECONDARY Change in Patient Impression of Change in Symptoms of PAH From Baseline to Week 8	5; 1; 3; 0; 0	—
SECONDARY Change in Patient Impression of Change on Time Spent Dealing With Therapy From Baseline to Week 8	8; 0; 1; 0; 0	—
SECONDARY Change in Patient Impression of Change of Satisfaction With Therapy From Baseline to Week 8	7; 2; 0; 0; 0	—
SECONDARY Change in Total Weekly Time Spent to Gather/Set-up Materials Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol	34.9; 27.0	0.250
SECONDARY Change in Total Weekly Time Spent to Connect Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol	23.2; 18.7	0.207
SECONDARY Change in Total Weekly Time Spent to Change Dressing With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol	31.4; 28.6	0.297
SECONDARY Change in Total Weekly Time Spent to Prepare Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol	109.0; 47.8	0.004 sig
SECONDARY Change in Total Number of Times Daily Required to Disconnect Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol	7.7; 4.1	—
SECONDARY Change in Total Number of Times Daily Required to Check Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol	19.2; 12.2	—
SECONDARY Change in Total Number of Times Daily Infusion Pump Alarms With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol	2.4; 0.8	—

Eligibility Criteria

Inclusion Criteria

Age 18 to 70 years
Diagnosis of 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 (Grade of A or B on the Child-Pugh Classification Scale)or PAH associated with drug or toxins or 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
Have any other type of PAH due to conditions other than noted in the above inclusion criteria, including but not limited to PAH related to thrombotic or embolic disease
Have any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis)
Changes to chronic PAH therapy (i.e., new therapy added within last 30 days[including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil] or PAH medication discontinued within 7 days of study entry.
Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
Central venous line infection within the past 30 days.
Previous documented evidence of significant parenchymal lung disease
Evidence or history of left-sided heart disease
Musculoskeletal disorder or any other disease, which is thought to limit ambulation, or be connected to a machine that is not portable
Uncontrolled hypertension, chronic renal insufficiency, or active infection.
Use of investigational drug within past 30 days.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00373360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.