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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01027949




Registration number
NCT01027949
Ethics application status
Date submitted
4/12/2009
Date registered
9/12/2009
Date last updated
10/05/2021

Titles & IDs
Public title
An Open-Label Extension Trial of UT-15C Sustained-release (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
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

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

Experimental: Oral Treprostinil - Subjects 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


Treatment: Drugs: Oral Treprostinil
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
Change in Exercise Capacity at Month 12
Timepoint [1] 0 0
From First Visit (Visit 1) to Month 12

Eligibility
Key inclusion criteria
1. 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).

2. The subject voluntarily gave informed consent to participate in the study.

3. 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.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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).

2. 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.

3. 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.

4. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/02/2020
Sample size
Target
Accrual to date
Final
894
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside West
Recruitment hospital [2] 0 0
Heart/Lung Transplant Unit - St. Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
4032 - Chermside West
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment outside Australia
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Jerusalem
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Ramat Gan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
United Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01027949
Trial related presentations / publications
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01027949