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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00325442




Registration number
NCT00325442
Ethics application status
Date submitted
11/05/2006
Date registered
12/05/2006
Date last updated
2/08/2017

Titles & IDs
Public title
FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)
Scientific title
A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension
Secondary ID [1] 0 0
TDE-PH-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oral treprostinil (UT-15C) sustained release tablets
Treatment: Drugs - Placebo

Active comparator: Active - Subjects assigned to active therapy with UT-15C 0.25, 0.5, 1, or 5 mg oral tablets.

Placebo comparator: Placebo Arm - Subjects assigned to placebo 0.25, 0.5, 1, or 5 mg oral tablets.


Treatment: Drugs: Oral treprostinil (UT-15C) sustained release tablets
UT-15C 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours

Treatment: Drugs: Placebo
Placebo 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Six Minute Walk Distance (6MWD)
Timepoint [1] 0 0
Baseline and 16 Weeks
Secondary outcome [1] 0 0
Borg Dyspnea Score
Timepoint [1] 0 0
Baseline and 16 Weeks
Secondary outcome [2] 0 0
Clinical Worsening Assessment
Timepoint [2] 0 0
Baseline and 16 Weeks
Secondary outcome [3] 0 0
Dyspnea-Fatigue Index
Timepoint [3] 0 0
Baseline and 16 Weeks
Secondary outcome [4] 0 0
World Health Organization Functional Classification for PAH
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Six Minute Walk Distance (6MWD)
Timepoint [5] 0 0
Baseline and 12 weeks
Secondary outcome [6] 0 0
Six Minute Walk Distance (6MWD)
Timepoint [6] 0 0
Baseline and 8 weeks
Secondary outcome [7] 0 0
Six Minute Walk Distance (6MWD)
Timepoint [7] 0 0
Baseline and 4 weeks
Secondary outcome [8] 0 0
Change in Symptoms of PAH From Baseline to Week 16
Timepoint [8] 0 0
Baseline and 16 weeks

Eligibility
Key inclusion criteria
* Between 12 and 70 years of age, inclusive.
* Body weight at least 45 kg (approximately 100 pounds).
* PAH that is either idiopathic/heritable (including PAH associated with appetite suppressant/toxin use); PAH associated with repaired congenital systemic-to-pulmonary shunts (repaired = 5 years); PAH associated with collagen vascular disease; or PAH associated with HIV.
* Baseline 6-minute walk distance between 150 and 450 meters, inclusive.
* Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days.
* Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
* Reliable and cooperative with protocol requirements.
Minimum age
12 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Nursing or pregnant.
* Received a prostacyclin within the past 30 days.
* PAH due to conditions other than noted in the above inclusion criteria.
* History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease.
* Use of an investigational drug within 30 days of Baseline.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
354
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
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United States of America
State/province [5] 0 0
Illinois
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United States of America
State/province [6] 0 0
Iowa
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United States of America
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Maine
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
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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
State/province [29] 0 0
Alberta
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Canada
State/province [30] 0 0
British Columbia
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Canada
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Ontario
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Canada
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Quebec
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France
State/province [33] 0 0
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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Germany
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Hannover
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Ireland
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Dublin
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Israel
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Jerusalem
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Israel
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Petach Tikva
Country [41] 0 0
Israel
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Ramat Gan
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Italy
State/province [42] 0 0
Bologna
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Italy
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Rome
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Netherlands
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Amsterdam
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Poland
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Warsaw
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Spain
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Barcelona
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Spain
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Madrid
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United Kingdom
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Cambridge
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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Newcastle

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

Ethics approval
Ethics application status

Summary
Brief summary
This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16.

Patients who completed all assessments for 16-weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).
Trial website
https://clinicaltrials.gov/study/NCT00325442
Trial related presentations / publications
Tapson VF, Torres F, Kermeen F, Keogh AM, Allen RP, Frantz RP, Badesch DB, Frost AE, Shapiro SM, Laliberte K, Sigman J, Arneson C, Galie N. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients on background endothelin receptor antagonist and/or phosphodiesterase type 5 inhibitor therapy (the FREEDOM-C study): a randomized controlled trial. Chest. 2012 Dec;142(6):1383-1390. doi: 10.1378/chest.11-2212.
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/study/NCT00325442