Rapid Switch From Flolan to Remodulin in the Outpatient Clinic

NCT00643604 | Terminated Phase 4 Results

• 1 other identifier: RIV-PH-413
• Study Type: interventional
• Target: 7
• 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

Hypertension, Pulmonary

Keywords

Pulmonary arterial hypertension; treatment satisfaction; rapid switch; remodulin; Quality of life

Outcome Measures

Primary Outcomes (1)

• Change in Six Minute Walk Distance

  Baseline and Week 8

Secondary Outcomes (13)

• Change in WHO Functional Classification

  Baseline and Week 8

• Change in Borg Dyspnea Score Immediately After Six Minute Walk

  Baseline and Week 8

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

  Baseline and Week 8

• Change in Score on Treatment Satisfaction Questionnaire for Medication

  Baseline and Week 8

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

  Baseline and Week 8

Study Arms (1)

treprostinil sodium

EXPERIMENTAL

all subjects had switched from IV epoprostenol to IV treprostinil sodium

Drug: treprostinil sodium

Interventions

treprostinil sodium DRUG

rapid switch from intravenous epoprostenol on CADD ambulatory pump to intravenous treprostinil sodium

Also known as: Remodulin, Flolan

treprostinil sodium

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• United Therapeutics: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

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

Limitations and Caveats

The main limitations of this study are the small sample size, open-label design and relatively short duration of follow-up.

Results Point of Contact

• Title: Remodulin Program Leader
• Organization: United Therapeutics Corporation

clinicalrecordsmanagement@unither.com

919-485-8350

Study Officials

• Victor Tapson, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: March 20, 2008
• First Posted: March 26, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2012
• Last Updated: January 3, 2024
• Results First Posted: June 21, 2013

Record last verified: 2013-06

Locations

US (1)