Clinical trialNCT00439946TerminatedPhase 4Interventional

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

SponsorUnited TherapeuticsEnrollment8Pulmonary Arterial Hypertension

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Evelyn Horn, MD
Weill Medical College of Cornell University
Principal Investigator
clinicaltrials.gov ↗
Remzi Bag, MD
INTEGRIS Baptist Medical Center
Principal Investigator
clinicaltrials.gov ↗
Teresa DeMarco, MD
University of California, San Francisco
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California San Francisco (ucsf) Medical Center
San Francisco, California, United States
the New York-Presbyterian Hospital Weill Cornell Medical Center
New York, New York, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Treprostinil →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 28 Feb 2007
Primary completion: 30 Sept 2009
Completion: 31 Mar 2011
Last update posted: 3 Jan 2024
Registered enrollment: 8
Registry id: NCT00439946

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.