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

NCT00373360 | Completed Phase 4 Results

• 1 other identifier: RIV-PH-411
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertension; PAH; Remodulin; treprostinil; Quality of Life; Rapid Switch

Outcome Measures

Primary Outcomes (1)

• Change in the Distance Transversed During the 6 Minute Walk Test From Baseline to Week 8.

  Baseline and Week 8

Secondary Outcomes (24)

• Change in Borg Dyspnea Score Immediately After Six Minute Walk Test From Baseline to Week 8

  Baseline and Week 8

• Change in World Health Organization (WHO) Functional Classification of PAH From Baseline to Week 8

  Baseline and Week 8

• Change in Symptoms of Dyspnea From Baseline to Week 8

  Baseline and Week 8

• Change in Symptoms of Edema From Baseline to Week 8

  Baseline to Week 8

• Change in Symptoms of Orthopnea From Baseline to Week 8

  Baseline and Week 8

Study Arms (1)

1

EXPERIMENTAL

Drug: treprostinil sodium

Interventions

treprostinil sodium DRUG

rapid switch from intravenous epoprostinol to intravenous remodulin on the CADD ambulatory pump

Also known as: Remodulin, Flolan

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Nursing or pregnant woman
• 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.

Sponsors & Collaborators

• United Therapeutics: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

treprostinil; Epoprostenol

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins I; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Rex Mauthe; Senior Director, Regulatory Affairs
• Organization: United Therapeutics Corporation

rmauthe@unither.com

919-485-8350

Study Officials

• Omar Minai, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Study Start: September 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: January 7, 2013
• Results First Posted: January 7, 2013

Record last verified: 2013-01

Locations

US (1)