Remodulin® to Oral Treprostinil Transition - Full Text View

Purpose

This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV) or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR) tablets).

This study will consist of an in-hospital transition phase, dose optimization/evaluation phase, and follow up phase.

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: UT-15C SR	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter, Open-Label Study of the Safety and Tolerability of Transitioning From Remodulin® to Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Treprostinil Treprostinil sodium

U.S. FDA Resources

Further study details as provided by United Therapeutics:

Primary Outcome Measures:

Successful transition from parenteral Remodulin to UT-15C [ Time Frame: Up to 24 weeks; then throughout follow-up phase until study completion ] [ Designated as safety issue: Yes ]
TO assess the tolerability and safety of transitioning subjects from Remodulin to UT-15C SR in four weeks or less.

Secondary Outcome Measures:

Six-minute walk distance [ Time Frame: Baseline, Weeks 0, 1, 2, 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion ] [ Designated as safety issue: No ]
Borg dyspnea score [ Time Frame: Baseline, Weeks 0, 1, 2, 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion ] [ Designated as safety issue: Yes ]
Combined walk distance / Borg dyspnea score [ Time Frame: Baseline, Weeks 0, 1, 2, 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion ] [ Designated as safety issue: Yes ]
Quality of life, assessed by the Cambridge Pulmonary Hypertension Outcome Review questionnaire & Treatment Satisfaction Questionnaire of Medication [ Time Frame: Baseline, Weeks 12 and 24; then every 3 months during follow-up phase until study completion ] [ Designated as safety issue: No ]
WHO functional class [ Time Frame: Baseline, Weeks 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion ] [ Designated as safety issue: Yes ]
Dyspnea-fatigue index [ Time Frame: Baseline, Weeks 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion ] [ Designated as safety issue: Yes ]
Symptoms of PAH [ Time Frame: Baseline, Weeks 0, 1, 2, 4, 8, 12, 20 and 24; then every 3 months during follow-up phase until study completion ] [ Designated as safety issue: Yes ]
Pharmacokinetics [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Blood samples to be drawn from each subject at time 0 and times 2, 4, 5, 6, 8 and 12 hours after time 0 for a total of 7 samples.
Hemodynamics [ Time Frame: Screening and Week 24 ] [ Designated as safety issue: No ]
Safety [ Time Frame: up to 24 weeks; then ongoing throughout follow-up phase until study completion ] [ Designated as safety issue: Yes ]
i.e., adverse events, clinical laboratory parameters, vital signs, echocardiograms, electrocardiograms

Estimated Enrollment:	30
Study Start Date:	April 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.

Eligibility

Ages Eligible for Study:	15 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Between 15 and 80 years of age, inclusive, weigh at least 40 kg and have a diagnosis of PAH
Have stable disease as confirmed by recent right heart catheterization and a Baseline 6MWD of at least 250 meters
Have been receiving Remodulin for at least 90 days and at a stable dose for at least 30 days prior to the Baseline visit; the dose of Remodulin must be between 25-75 ng/kg/min, inclusive
Must be also receiving an endothelin receptor antagonist (ERA) and/or a phosphodiesterase-5 inhibitor (PDE-5i) for at least 90 days and have been at a stable dose for at least 30 days prior to Baseline

Exclusion Criteria:

WHO functional class III and IV subjects will be excluded

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588405

Contacts

Contact: Meredith Howell, PharmD	919-425-5308	mhowell@unither.com
Contact: Jen Kates	816-605-1710	jkates@unither.com

Locations

United States, Arizona
Arizona Pulmonary Specialists	Recruiting
Phoenix, Arizona, United States, 85013
Contact: Lorraine Stroud, LPN, CCRC 602-271-0832 lorraine-research@hotmail.com
Principal Investigator: Jeremy Feldman, MD
United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Ellen Newton-Lovato, RN 314-454-8717 ELOVATO@DOM.wustl.edu
Principal Investigator: Murali Chakinala, MD
United States, New York
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Contact: Karen Frutiger, RN 585-486-0869 karen_frutiger@urmc.rochester.edu
Principal Investigator: James White, MD, PhD

Sponsors and Collaborators

United Therapeutics

Investigators

Study Chair:

Cynthia Madden, MD, MPH

Senior Clinical Research Physician

More Information

No publications provided

Responsible Party:	United Therapeutics
ClinicalTrials.gov Identifier:	NCT01588405 History of Changes
Other Study ID Numbers:	TDE-PH-205
Study First Received:	January 6, 2012
Last Updated:	January 18, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by United Therapeutics:

Pulmonary Arterial Hypertension
UT-15C SR
PAH

Additional relevant MeSH terms:

Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013