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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01027949




Trial ID
NCT01027949
Ethics application status
Date submitted
4/12/2009
Date registered
8/12/2009
Date last updated
28/11/2017

Titles & IDs
Public title
An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension
Scientific title
An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension
Secondary ID [1] 0 0
TDE-PH-304
Universal Trial Number (UTN)
Trial acronym
FREEDOM-EXT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Treprostinil diethanolamine

Experimental: Treprostinil diethanolamine (UT-15C) - All open will receive active study drug


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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Continued therapy effect on exercise capacity as assessed by a 6-Minute Walk Test
Timepoint [1] 0 0
Once, after one year of therapy with UT-15C SR.
Primary outcome [2] 0 0
Long-term safety as assessed by clinical laboratories - After one year exposure to UT-15C clinical laboratorial assessments will occur 1 time/year through study completion until either drug receives regulatory approval in a particular region or the sponsor discontinues the study.
Timepoint [2] 0 0
Performed at each study scheduled visit
Primary outcome [3] 0 0
Long-term safety as assessed by adverse events - Telephone calls will occur at a minimum 1 time/month through study completion until either drug receives regulatory approval in a particular region or the sponsor discontinues the study.
Timepoint [3] 0 0
Performed monthly during monthly telephone calls

Eligibility
Key inclusion criteria
Participation in study TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301,
TDE-PH-302,TDE-PH-308 or any additional UT-15C SR clinical protocol is required. Subjects
must complete all assessments in one of these studies to be eligible.
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside West
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [4] 0 0
St. Vincent's Hospital - Sydney
Recruitment postcode(s) [1] 0 0
4032 - Chermside West
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
State/province [3] 0 0
California
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Colorado
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Florida
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Georgia
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Illinois
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Iowa
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Minnesota
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Missouri
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Nebraska
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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United States of America
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Wisconsin
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Austria
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Innsbruck
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Leuven
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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France
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Pessac Cedex
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France
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Brest
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France
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Clamart
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France
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Lille Cedex
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France
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Lyon
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France
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Montpellier cedex 5
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Germany
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Dresden
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Germany
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Greifswald
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Heidelberg
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India
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Gujarat
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India
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Karnataka
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India
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Maharashtra
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India
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Ahmedabad
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India
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Chennai
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India
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Coimbatore
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India
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Hyderabad
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India
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New Delhi
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Ireland
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Dublin
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Israel
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Tel Aviv
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah Tiqva
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Israel
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Ramat Gan
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Italy
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Bologna
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Italy
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Naples
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Italy
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Rome
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Mexico
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Guadalajara
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Mexico
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Mexico City
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Mexico
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Monterrey
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Netherlands
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Amsterdam
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Poland
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Kraków
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Poland
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Warsaw
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Wroclaw
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Lisbon
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O'Porto
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Guaynabo
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Spain
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Barcelona
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Madrid
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Lund
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Cambridge
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Glasgow
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London
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United Kingdom
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Newcastle
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United Kingdom
State/province [81] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
United Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study provides, or continues to provide, UT-15C SR (treprostinil diethanolamine) to
eligible patients with pulmonary arterial hypertension who have completed protocols
TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, TDE-PH-308 studies or any
additional UT-15C SR clinical protocols evaluating subjects with PAH. The study assesses the
long term safety of UT-15C and the effect of continued treatment with UT-15C on exercise
capacity after one year of treatment.
Trial website
https://clinicaltrials.gov/show/NCT01027949
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeff Sigman
Address 0 0
United Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries