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Pulmonary Arterial HypertensionPhase 3NCT01560637

An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

A Phase 3 study testing UT-15C (treprostinil diolamine) in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 153 sites in 23 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 is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
UT-15C (treprostinil diolamine)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
471 participants
Where
153 sitesin 23 countries
Study dates
11 Sep 2013to 12 Aug 2021
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participated in United Therapeutics Study TDE-PH-310
  • All women of childbearing potential (WOCBP) must have practiced true abstinence from intercourse when it was in line with their preferred and usual lifestyle or used 2 different forms of highly effective contraception for the duration of the study and for at least 30 days after discontinuing study medication.
  • Males who participated in the study must have used a condom during the length of the study and for at least 48 hours after their last dose of study medication.

Who cannot join

  • The subject was pregnant or lactating.
  • The subject had received infused or inhaled prostacyclin therapy for 29 days or more.
  • The subject was prematurely discontinued from TDE-PH-310 for reasons other than a clinical worsening event.
  • The subject developed a concurrent illness or condition during the conduct of TDE-PH-310 which, in the opinion of the Investigator, would represent a risk to their overall health if they enrolled in this study.

Trial locations and contacts

153 sites in 23 countries.

153 sites in 23 countries

United States38 sites

  • Asheville Cardiology Associates

    Asheville, North Carolina, 28803

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Augusta University

    Augusta, Georgia, 30912

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Piedmont - Georgia Lung Associates

    Austell, Georgia, 30106

  • University of Maryland

    Baltimore, Maryland, 21201

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Indiana University Hospital

    Carmel, Indiana, 46032

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University Hospital

    Cleveland, Ohio, 44106

  • Ohio State University

    Columbus, Ohio, 43321

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • University of California, San Francisco-Fresno

    Fresno, California, 93701

  • University of Florida

    Gainesville, Florida, 32610

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 55242

  • University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine

    Jacksonville, Florida, 32209

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90211

  • Kentuckiana Pulmonary Associates

    Louisville, Kentucky, 40202

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23507

  • Nebraska Medical Center

    Omaha, Nebraska, 68198-5990

  • HeartCare Midwest

    Peoria, Illinois, 61614

  • Perelman Center for Advanced Medicine, University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Arizona Pulmonary Specialists, Ltd.

    Phoenix, Arizona, 85012

  • University of Pittsburgh Medical Center - Presbyterian Cardiovascular Institute

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health and Science University

    Portland, Oregon, 97201-3098

  • Legacy Research Institute

    Portland, Oregon, 97210

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • University of Rochester

    Rochester, New York, 14642

  • University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program

    Sacramento, California, 95817

  • David Geffen School of Medicine

    Torrance, California, 90502

  • Beaumont Health

    Troy, Michigan, 48085

  • University of Arizona

    Tucson, Arizona, 85724

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

China16 sites

  • Beijing Chao-Yang Hospital

    Beijing, Beijing Municipality, 100020

  • Peking Union Medical College Hospital

    Beijing, 100005

  • Beijing Shijitan Hospital

    Beijing, 100038

  • Chinese PLA General Hospital

    Beijing, 100853

  • Xiangya Hospital

    Changsha, Hunan, 410008

  • West China Hospital

    Chengdu, Sichuan, 610047

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

  • The Second Affiliated Hospital of Nanchang Medical University

    Nanchang, Jiangxi, 330006

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • The Affiliated Hospital of Qingdao University

    Qingdao, 26603

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200120

  • Renji Hospital of Shanghai Jiaotong University

    Shanghai, 200001

  • Shanghai Pulmonary Hospital of Tongji University

    Shanghai, 200433

  • Shenyang General Hospital of Shenyang Military Command

    Shenyang, 110015

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei, 430022

Other trials in China

Germany13 sites

  • Bergmannsheil Berufsgenossenschaftliche Universitätsklinik GmbH

    Bochum, North Rhine-Westphalia, 44789

  • Universitätsklinikum Köln

    Cologne, North Rhine-Westphalia, 50937

  • Technische Universität Dresden

    Dresden, Saxony, 01307

  • Herzzentrum Duisburg

    Duisburg, North Rhine-Westphalia, 47137

  • Universitätsmedizin Greifswald

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Universitätskrankenhaus Hamburg-Eppendorf

    Hamburg, 20246

  • Thoraxklinik am Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69126

  • Universitätsklinikum des Saarlandes

    Homburg, Saarland, 66424

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Universitätsmedizin der Johannes Gutenberg Universität

    Mainz, Rhineland-Palatinate, 55131

  • Ludwig-Maximilians-Universitat Munchen

    München, Bavaria, 81377

  • Universitätsklinikum Regensburg

    Regensburg, Bavaria, 93053

  • Missionsarztliche Klinik Wurzburg gGmbH

    Würzburg, Bavaria, 97074

Other trials in Germany

India13 sites

  • Care Institute Medical Sciences

    Ahmedabad, Gujarat, 38006

  • Narayana Institute of Cardiac Sciences

    Bangalore, Karnataka, 560 099

  • Apollo Hospital

    Chennai, Tamil Nadu, 600006

  • G. Kuppuswamy Naidu Memorial Hospital

    Coimbatore, Tamil Nadu, 641037

  • Apollo Hospitals International, Ltd.

    Gandhinagar, Gujarat, 382428

  • Medanta - The Medicity

    Gurgaon, Haryana, 122 001

  • CARE Hospital

    Hyderabad, Andhra Pradesh, 500 001

  • Mediciti Hospital

    Hyderabad, Andhra Pradesh, 500 063

  • KEM Hospital

    Mumbai, Maharashtra, 400012

  • King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College

    Mumbai, Maharashtra, 400012

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060

  • Indraprastha Apollo Hospital

    New Delhi, National Capital Territory of Delhi, 110076

  • Ruby Hall Clinic

    Pune, Maharashtra, 411 001

Other trials in India

Australia8 sites

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Prince Charles Hospital

    Chermside, Queensland, 4032

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Nepean Hospital

    Kingswood, New South Wales, 2751

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Saint Vincents Hospital

    Sydney, New South Wales, 2010

  • Macquarie University

    Sydney, New South Wales, 2109

Other trials in Australia

Brazil8 sites

  • Hospital das Clínicas da Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais, 30130-100

  • Hospital Madre Teresa

    Belo Horizonte, Minas Gerais, 30380-090

  • Hospital das Clínicas da Faculdade de Medicina de Botucatu- UNESP

    Botucatu, São Paulo, 18618-970

  • Hospital das Clinicas da Universidade Federal de Goias

    Goiânia, Goiás, 74605-050

  • Complexo Hospitalar Santa Casa de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, São Paulo, 05403-000

  • Escola Paulista de Medicina, Universidade Federal de São Paulo

    São Paulo, São Paulo

  • Hospital Alemão Oswaldo Cruz

    São Paulo, 01323-020

Other trials in Brazil

France6 sites

  • Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon

    Besançon, Franche-comte, 25030

  • Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

    Lille, Hauts-de-France, 59037

  • Centre Hospitalier Universitaire Hopital Nord

    Marseille, Provence-Alpes-Côte d'Azur Region, 13015

  • CHU de Montpellier

    Montpellier, Languedoc-roussillon, 34295

  • Hopital Haut-Leveque, CHU Bordeaux

    Pessac, Aquitaine, 33064

  • Hopital Brabois

    Vandœuvre-lès-Nancy, Limousin, Lorraine, 54500

Other trials in France

Argentina5 sites

  • Hospital Italiano de Buenos Aires

    Buenos Aires, Distrito Federal, C1181ACH

  • Sanatorio de la Trinidad Mitre

    Buenos Aires

  • Sanatorio San José

    CABA, Buenos Aires, C1425DUH

  • Hospital Italiano Garibaldi

    Rosario, Santa Fe Province, S2001OAD

  • Hospital Dr. José María Cullen

    Santa Fe, S3000EOY

Other trials in Argentina

Israel5 sites

  • Rambam Health Corp.

    Haifa, 31096

  • Carmel Medical Center

    Haifa, 34362

  • Hadassah Medical Center

    Jerusalem, 91120

  • Rabin Medical Center

    Petach Tikvah, Petah Tiqwa, 49100

  • The Chaim Sheba Medical Center at Tel Hashomer

    Tel HaShomer, Tel Aviv, 52621

Other trials in Israel

South Korea5 sites

  • Gachon University Gil Medical Center

    Incheon, 405-760

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Canada4 sites

  • Respiratory Research Foundation

    Calgary, Alberta, T1Y 6J4

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Lawson Health Research Institute

    London, Ontario, N6A 5A5

  • Vancouver Coastal Health

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Italy4 sites

  • Azienda Ospedaliera Universitaria

    Naples

  • Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)

    Palermo, 90127

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia, 27100

  • Azienda Policlinico Umberto I di Roma

    Roma, 00161

Other trials in Italy

Poland4 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15276

  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu

    Krakow, 61848

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II

    Małogoskie, 31202

  • Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina

    Otwock

Other trials in Poland

Taiwan4 sites

  • Veterans General Hospital-Kaohsiung

    Kaohsiung City, 81362

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, Tainan CITY, 70403

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

United Kingdom4 sites

  • Royal Free Hospital

    London, England, NW3 2QG

  • Freeman Hospital

    Newcastle upon Tyne, England, NE7 7DN

  • Papworth Hospital

    Papworth Everard, Cambridgshire, CB3 8RE

  • Royal Hallamshire Hospital

    Sheffield, England, S10 2JF

Other trials in United Kingdom

Austria2 sites

  • Krankenhaus Elisabethinen Linz

    Linz, Upper Austria, 4020

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Chile2 sites

  • Centro de Investigaciones TASOL

    Santiago, Santiago Metropolitan, 7500710

  • Clínica Tabancura

    Vitacura, Santiago Metropolitan, 7650018

Other trials in Chile

Denmark2 sites

  • Aarhus Universitetshospital, Skejby

    Aarhus, 8200

  • Rigshospitalet-Copenhagen University Hospital

    Copenhagen, 2100

Other trials in Denmark

Greece2 sites

  • University General Hospital of Attikon

    Athens, Attica, 12462

  • General Hospital of Thessaloniki, "G.Papanikolaou"

    Thessaloniki, Macedoni, 57010

Other trials in Greece

Mexico2 sites

  • Unidad de Investigacion Clinica en Medicina S.C.

    Monterrey, Nuevo León, 64718

  • Instituto Nacional de Cardiologia Ignacio Chavez

    Tlalpan, Mexico City, 14080

Other trials in Mexico

Netherlands2 sites

  • Vrije Universiteit Medisch Centrum

    Amsterdam, North Holland, 1081 HV

  • Universitair Medisch Centrum Sint Radboud

    Nijmegen, Gelderland, 6525 GA

Other trials in Netherlands

Singapore2 sites

  • National University Hospital

    Singapore, 119228

  • National Heart Centre Singapore

    Singapore, 168 752

Other trials in Singapore

Sweden2 sites

  • Sahlgrenska University Hospital

    Gothenburg, Västra Götaland County, 413 45

  • Karolinska University Hospital Solna

    Stockholm, 171 76

Other trials in Sweden

About this study

Official title: Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310

This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.

Being tested
UT-15C (treprostinil diolamine)
Keywords
PAH, PH, FREEDOM, 6 minute walk test, treprostinil, open label
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.

  • UT-15C (treprostinil diolamine)Drug

    UT-15C extended release oral tablet three times daily

Study groups in NCT01560637
Study groupRoleWhat they receive
UT-15CExperimentalOpen label access
Receives: Drug: UT-15C (treprostinil diolamine)

What is being measured

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

  1. Number of Adverse Events

    All subjects who received oral treprostinil in TDE-PH-311 were included in the Safety population. All AEs were captured from the time the ICF was signed. All AEs were followed until resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for up to 30 days if the AE extended beyond the final visit. All SAEs were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final visit. The overall summary of AEs includes the number of subjects with any AE, the number of subjects with any study drug-related AEs, the number of subjects with AEs leading to study drug withdrawal, the number of subjects with any serious AEs, the number of subjects with any severe AEs, and the number of subjects with any study drug-related severe/serious AEs. AEs were coded using the Medical Dictionary for Regulatory Activities.

    Measured: Participants will be followed every 12 weeks, at minimum, until they discontinue the study or the study is discontinued by the sponsor or for a period up to 2.5 years

Secondary outcomes (4)

  1. Change in 6-Minute Walk Distance From Baseline

    A summary of change from Baseline in 6MWD at Week 48 for the Safety Population is provided. The Safety Population is all subjects who received oral treprostinil in TDE-PH-311.

    Measured: Baseline to Week 48

  2. Change in Borg Dyspnea Score From Baseline to Week 48

    Change in Borg Dyspnea Score from at Week 48 is provided for the Safety Population (all subjects who received oral treprostinil in TDE-PH-311).

    The Borg Dyspnea Scale is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and was administered during six-minute walk testing (6MWT), one of the most common and frequently used measures to assess disease severity in PAH. The numbers on the scale are as follows: 0 (no shortness of breath [SOB]), 0.5 (very very slight SOB), 1 (very slight SOB), 3 (moderate SOB), 4 (somewhat severe SOB), 5 (severe SOB), 7 (very severe SOB), 9 (very very severe SOB), 10 (maximal SOB).

    Measured: Baseline to Week 48

  3. Change From Baseline to Week 48 in WHO Functional Class

    Change from Baseline at Week 48 in WHO FC in the Safety Population (all subjects who received oral treprostinil in TDE-PH-311).

    The World Health Organization functional classification (WHO-FC) is a clinician-rated assessment used widely to assess PAH severity and functioning.

    Class I (least severe): Patients are without limitation of physical activity.

    Class II: Patients are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.

    Class III: Marked limitation of physical activity. They are comfortable at rest.

    Class IV (most severe): Inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure.

    Measured: Baseline to Week 48

  4. Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 48

    Change in N-terminal pro-brain natriuretic peptide from Baseline at Week 48 for the Safety Population (any subject who received oral treprostinil in TDE-PH-311)

    Measured: Baseline to Week 48

Timeline

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

  1. First posted22 Mar 2012 (estimated)
  2. Study start11 Sep 2013
  3. Primary completion12 Aug 2021
  4. Study completion12 Aug 2021

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
471 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01560637
Sponsor's protocol ID
TDE-PH-311
Status last verified
May 2022
First submitted
9 Mar 2012
Last updated
2 Jun 2022
Data monitoring committee
Yes

Publications

  • Grunig E, Rahaghi F, Elwing J, Vizza CD, Pepke-Zaba J, Shen J, Yao H, Hage A, Rosenkranz S, Vonk M, Balasubramanian V, Yuanhua Y, Yu Z, Lordan J, Cadaret L, Grover R, Ousmanou A, Seaman S, Deng C, Broderick M, White RJ; FREEDOM-EV Investigators. Oral Treprostinil is Associated with Improved Survival in FREEDOM-EV and its Open-Label Extension. Adv Ther. 2024 Feb;41(2):618-637. doi: 10.1007/s12325-023-02711-x. Epub 2023 Dec 6.

    PubMed 38055186

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing UT-15C (treprostinil diolamine) in people with Pulmonary Arterial Hypertension, run by United Therapeutics at 153 sites in 23 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 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in United States, China, Germany, India, Australia and 18 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 2 Jun 2022). 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?

Number of Adverse Events (time frame: Participants will be followed every 12 weeks, at minimum, until they discontinue the study or the study is discontinued by the sponsor or for a period up to 2.5 years). 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 NCT01560637, which also lists 1 linked publication.

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 2 Jun 2022.

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