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Pulmonary Arterial HypertensionPhase 3FREEDOM-EXTNCT01027949

An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension

A Phase 3 study testing Oral Treprostinil in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 134 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, and TDE-PH-308. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Oral Treprostinil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
894 participants
Where
134 sitesin 20 countries
Study dates
16 Jan 2007to 12 Feb 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The subject remained on study drug and completed all assessments during the Treatment Phase of the previous study (TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE PH-302, or TDE-PH-308) OR the subject permanently discontinued study drug during the Treatment Phase of the previous study due to clinical worsening (as defined in the protocol of the previous study), completed premature termination assessments prior to discontinuing study drug, completed all remaining scheduled study visits, AND received placebo during the Treatment Phase of the previous studies OR the subject was randomized into Group 1 or Group 2 in Study TDE PH 202, permanently discontinued study drug during the 12-week Treatment Phase due to clinical worsening, completed all premature termination assessments prior to discontinuing study drug, and completed all remaining scheduled study visits and assessments (with the exception of the hemodynamic measurements) through Week 12. Such subjects should have started treatment with oral treprostinil in the open-label study at 0.25 mg twice daily (BID).
  • The subject voluntarily gave informed consent to participate in the study.
  • Women of childbearing potential includes any female who had experienced menarche and who had not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or was not postmenopausal (defined as amenorrhea for at least 12 consecutive months). Sexually active women of childbearing potential must have used 2 effective forms of contraception during the length of the study. Medically acceptable forms of effective contraception included: (1) approved hormonal contraceptives (such as birth control pills), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, (3) an intrauterine device, (4) partner vasectomy, or (5) abstinence. Males participating in the study must have used a condom during the length of the study, and for at least 48 hours after discontinuing study medication. Protocol Amendment A.1AU included the required assessment for Austrian subjects to perform urine pregnancy tests every 4 weeks during the study.

Who cannot join

  • The subject permanently discontinued study drug during the previous study (TDE PH 202, TDE-PH-203, TDE PH 205, TDE-PH-301, TDE-PH-302, or TDE PH 308) due to treatment-related adverse events (AEs).
  • The subject permanently discontinued study drug during the Treatment Phase of the previous study (TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, or TDE-PH-308) due to clinical worsening (as defined in those study protocols) and did not undergo premature termination assessments prior to discontinuing study drug, and/or did not complete all remaining study visits through the final scheduled visit.
  • The subject prematurely discontinued study drug during the Treatment Phase of the previous study due to clinical worsening (as defined in those study protocols), completed premature termination assessments prior to discontinuing study drug, completed all remaining scheduled study visits AND received oral treprostinil during the Treatment Phase of the previous study (TDE PH-202, TDE-PH-203, TDE-PH-301, TDE-PH-302, or TDE PH-308). Subjects enrolled in Study TDE-PH-202 who were randomized into the individual maximum tolerated dose (iMTD) group who clinically worsened could not participate. Subjects who permanently discontinued study drug during the 12-week Treatment Phase due to treatment-related AEs were not eligible even if they completed all remaining scheduled study visits. Subjects who permanently discontinued study drug during the 12 week Treatment Phase and did not undergo premature termination assessments prior to discontinuing study drug and/or who did not complete all remaining study visits through the Week 12 visit were also not eligible.
  • The subject developed any concurrent illness or condition during the conduct of the previous study, including but not restricted to: sleep apnea, chronic renal insufficiency, anemia, uncontrolled systemic hypertension, or left sided heart disease, unless their physician felt that entry into this study would not be detrimental to their overall health.

Trial locations and contacts

134 sites in 20 countries.

134 sites in 20 countries

United States61 sites

  • Alexandria Cardiology Clinic

    Alexandria, Louisiana, 71301

  • University of Michigan Health System

    Ann Arbor, Michigan, 48103

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • The Children's Hospital

    Aurora, Colorado, 80045

  • University of Colorado Health Science Center

    Aurora, Colorado, 80045

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Johns Hopkins Outpatient Center

    Baltimore, Maryland, 21287

  • The Kirklin Clinic

    Birmingham, Alabama, 35233

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Brigham and Woman's Hospital

    Boston, Massachusetts, 02114

  • University of North Carolina Hospitals

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • The University of Chicago Hospitals

    Chicago, Illinois, 60637

  • The Carl and Ethyl Linder Center for Research and Education at the Christ Church

    Cincinnati, Ohio, 45219

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0564

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43210

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • University of California, San Francisco-Fresno

    Fresno, California, 93701

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Texas Medical School

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Florida College of Medicine Jacksonville

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • West Los Angeles VA Healthcare Center

    Los Angeles, California, 90073

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095

  • Kentuckiana Pulmonary Associates

    Louisville, Kentucky, 40202

  • Aurora Cardiovascular Services

    Milwaukee, Wisconsin, 53215

  • Winthrop University Hospital

    Mineola, New York, 11501

  • University of Minnesota Medical Center, Fairview

    Minneapolis, Minnesota, 55455

  • Intermountain Medical Center

    Murray, Utah, 84157-7000

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-2650

  • Columbia University Medical Center

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-5300

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Arizona Pulmonary Specialists, Ltd.

    Phoenix, Arizona, 85013

  • Mayo Clinic Phoenix

    Phoenix, Arizona, 85054

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • Maine Medical Center

    Portland, Maine, 04102

  • Legacy Pulmonary Clinic

    Portland, Oregon, 97210

  • Oregon Health and Sciences University

    Portland, Oregon, 97239

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • Mary Parkes Center

    Rochester, New York, 14643

  • UC Davis Medical Center

    Sacramento, California, 95817

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • UCSD Medical Center

    San Diego, California, 30322

  • University of California San Francisco Medical Center

    San Francisco, California, 94118

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Washington University School of Medicine

    St Louis, Missouri, 63110-1093

  • Stanford University, Pulmonary and Critical Care Medicine

    Stanford, California, 94305-5351

  • The University of Toledo Medical Center

    Toledo, Ohio, 43614

  • Harbor-UCLA Medical Center

    Torrance, California, 90502

  • University Medical Center

    Tucson, Arizona, 85724

  • University of Arizona Clinical and Translational Science (CATS) Research Center

    Tucson, Arizona, 85724

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

India11 sites

  • Care Institute of Medical Sciences

    Ahmedabad, Gujarat, 380054

  • Life Care Institute of Medical Sciences & Research

    Ahmedabad, 380054

  • Narayana Hrudayalaya Hospitals

    Bangalore, Karnataka, 560034

  • Sri Ramachandra Medical College & Research Institute

    Chennai

  • G. Kuppuswamy Naidu Memorial Hospital

    Coimbatore

  • PRIME Hospitals

    Hyderabad, 500038

  • Asian Heart Institute & Research Centre Pvt. Ltd.

    Mumbai, Maharashtra, 400012

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Poona Hospital and Research Centre

    Pune, Maharashtra, 411030

  • Ruby Hall Clinic

    Pune

  • Queen's NRI Hospital

    Visakhapatnam

Other trials in India

France8 sites

  • PMAC, Clinique de Pneumologie

    Bernin

  • Centre d'Investigation Clinique Hôpital La Cavale Blanche - CHU Brest

    Brest

  • Hospital Antoine Beclere

    Clamart

  • Hospital Claude Huriez

    Lille

  • Hôpital Louis Pradel

    Lyon

  • CHU Arnaud de Villeneuve - Service maladies respiratoires

    Montpellier, 34295

  • Service Chirurgie Thoracique, Hôpital Haut Levêque

    Pessac, Pessac Cedex, 33604

  • Service de Pneumologie Centre de Competence pour l'HTAP- Pole des Voies Respiratoires Hôpital Larrey

    Toulouse

Other trials in France

Germany8 sites

  • Universitätsklinikum Dresden Abtl. Pneumologie

    Dresden, 01307

  • University Hospital Greifswald

    Greifswald, 17475

  • DRK Kliniken Berlin Köpenick

    Hamburg

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg

  • Universitätsklinkium Köln Klinik III für Innere Medizin

    Hamburg

  • Zentrum für Lungenhochdruck Thoraxklinik am Universitätsklinikum Heidelberg

    Hamburg

  • Medizinische Hochschule Hannover (MHH)

    Hanover

  • Dept. of Internal Medicine III University Heidelberg

    Heidelberg, 69120

Other trials in Germany

Canada6 sites

  • Peter Lougheed Centre

    Calgary, Alberta, T1Y 6J4

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Sir Mortimer B. Davis Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2

  • London Health Sciences Center Victoria Hospital

    Toronto, Ontario, N6A 4G5

  • Vancouver Coastal Health Authority Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Israel5 sites

  • Rambam Medical Center

    Haifa, 31096

  • The Lady Davis Carmel Medical Center

    Haifa

  • Hadassah Hebrew University Medical Center

    Jerusalem

  • Pulmonary Institute Rabin Medical Center (Belinson Kampus)

    Petah Tikva

  • Pulmonary Institute Chaim Sheba Medical Center

    Ramat Gan

Other trials in Israel

United Kingdom5 sites

  • Papworth Hospital

    Cambridge

  • Papworth Hospital NHS Foundation Trust

    Glasgow

  • Royal Free Hospital

    London

  • Freeman Hospital

    Newcastle

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

Other trials in United Kingdom

Australia4 sites

  • The Prince Charles Hospital

    Chermside West, 4032

  • Heart/Lung Transplant Unit - St. Vincent's Hospital

    Darlinghurst, 2010

  • The Alfred Hospital

    Melbourne, 3004

  • Royal Perth Hospital

    Perth

Other trials in Australia

Austria3 sites

  • Medizininische Universitaet Wien

    Vienna

  • Universitaetsklinik für Innere Medizin Innsbruck

    Vienna

  • Medical University Graz

    Wein

Other trials in Austria

China3 sites

  • Beijing Shijitan Hospital, Cadres Respiratory Department

    Beijing

  • Peking Union Medical College Hospital, Respiratory Medicine Department

    Beijing

  • Shanghai Pulmonary Hospital, Respiratory Medicine Department

    Shanghai

Other trials in China

Italy3 sites

  • Policlinico S. Orsola Malpighi - Università degli studi di Bologna

    Bologna

  • Azienda Ospedaliera di Rilievo Nazionale Monaldi - Cotugno-CTO Cardiologia S.U.N.

    Naples

  • Dipartimento di Scienze Cardiovascolari, Respiratorie e Morfologiche

    Rome

Other trials in Italy

Mexico3 sites

  • Instituto Nacional de Cardiologia

    Mexico City, 14080

  • Hospital Universitario de la UANL

    Monterrey, 64460

  • Unidad de Investigacion Clinica en Medicina S.C.

    Monterrey, 64718

Other trials in Mexico

Poland3 sites

  • Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawla II

    Krakow, 31-202

  • Europejskie Centrum Zdrowia Otwock

    Warsaw

  • Oddzial Kardiologiczny

    Wroclaw, 51-124

Other trials in Poland

Spain3 sites

  • Hospital Clínic I Provincial

    Barcelona

  • Hospital Vall d'Hebron

    Barcelona

  • Hospital 12 de Octubre

    Madrid

Other trials in Spain

Belgium2 sites

  • Department of Cardiology Erasme University Hospital

    Brussels

  • University Hospital Gasthuisberg

    Leuven

Other trials in Belgium

Netherlands2 sites

  • Radboud University Nijmegen Medical Center

    Amsterdam

  • VU Medish Centrum

    Amsterdam

Other trials in Netherlands

Ireland1 site

  • Pulmonary Hypertension Unit Centre for Lung Health Mater Misericordiae University Hospital

    Dublin

Other trials in Ireland

Portugal1 site

  • Servico de Cardiologia Hospital de Santa Marta

    Lisbon

Other trials in Portugal

Puerto Rico1 site

  • Auxilio Mutuo Hospital CardioPulmonary Research Center

    Guaynabo, 00968

Other trials in Puerto Rico

Sweden1 site

  • Skane University Hospital

    Lund, SE 22185

Other trials in Sweden

About this study

Official title: An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension

This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, and TDE-PH-308. The study assessed the long term safety of oral treprostinil and the effect of continued treatment with oral treprostinil on exercise capacity after 1 year of treatment.

Read the detailed description

This was an international, multicenter, open-label study designed to provide oral treprostinil for eligible subjects who participated in Studies TDE-PH-301, TDE-PH-302, TDE-PH-308, TDE-PH-202, TDE PH 203, and TDE-PH-205. Subjects randomly allocated to receive oral treprostinil in Studies TDE-PH-301, TDE-PH-302, or TDE-PH-308 and enrolled in this open-label study completed visits at Months 6, 12, 24, 36, and yearly visits thereafter. Subjects randomly allocated to receive placebo in Studies TDE-PH-301, TDE-PH-302, or TDE-PH-308 completed visits at Months 3, 6, 12, 24, 36, and yearly visits thereafter. Subjects that transitioned from Studies TDE-PH-202, TDE-PH-203, and TDE-PH-205 (that had an open-label study design) followed the regimen for subjects receiving oral treprostinil. A 6-Minute Walk Test (6MWT) and Borg dyspnea score were conducted at the visit which occurred 12 months after the subject's first exposure to oral treprostinil.

Adverse events (AEs) were reported continuously throughout the study; any AEs ongoing at the time of discharge from Studies TDE PH-301, TDE PH-302, TDE-PH-308, TDE-PH-202, TDE-PH-203, and TDE-PH-205 were recorded as AEs and marked as "ongoing from previous study" in the subject's electronic Case Report Form (eCRF). Study drug dosing and pulmonary arterial hypertension (PAH) concomitant medication usage were assessed at each scheduled study visit and recorded in the subject's eCRF.

Being tested
Oral Treprostinil
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral TreprostinilDrug

    Also called Treprostinil diethanolamine, treprostinil diolamine, UT-15C

    Oral sustained release tablet, twice or thrice daily. Open label study with active drug, no other intervention arms.

Study groups in NCT01027949
Study groupRoleWhat they receive
Oral TreprostinilExperimentalSubjects from previous studies TDE-PH-202 (NCT01104870), TDE-PH-203 (NCT01477333), and TDE-PH-205 (NCT01588405), TDE-PH-301 (NCT00325442), TDE-PH-302 (NCT00325403), or TDE PH-308 (NCT00887978). Subjects were instructed to take the appropriate amount of 0.125, 0.25, 0.5, 1, and/or 2.5 mg tablets based upon their prescribed dose. Investigators were instructed to increase the dose of oral treprostinil in the absence of dose limiting drug-related AEs to ensure each subject received the optimal clinical dose throughout the study
Receives: Drug: Oral Treprostinil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Exercise Capacity at Month 12

    Assess the effect of continued therapy with oral treprostinil on exercise capacity as assessed by the change from Baseline in 6-Minute Walk Test (6MWT) after 1 year of treatment. The 6MWT is the clinical standard for assessing subject functional status in the treatment of PAH and has been considered an objective measure of subject functional status by the American Thoracic Society. The distance a subject can walk in 6 minutes is recorded in meters.

    Measured: From First Visit (Visit 1) to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2009 (estimated)
  2. Study start16 Jan 2007
  3. Primary completion12 Feb 2020
  4. Study completion12 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
894 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01027949
Sponsor's protocol ID
TDE-PH-304
Acronym
FREEDOM-EXT
Status last verified
Apr 2021
First submitted
4 Dec 2009
Last updated
10 May 2021
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oral Treprostinil in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 134 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, India, France, Germany, Canada and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Exercise Capacity at Month 12 (time frame: From First Visit (Visit 1) to Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01027949.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.

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