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

NCT00439946 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-01-03

Study results available
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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.

Conditions

Interventions

DRUG

treprostinil

rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump

DEVICE

Crono Five ambulatory pump

Used for administration of IV Remodulin (treprostinil)

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Principal Investigators

  • Remzi Bag, MD · INTEGRIS Baptist Medical Center

  • Evelyn Horn, MD · Weill Medical College of Cornell University

  • Teresa DeMarco, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-09-30
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00439946 on ClinicalTrials.gov