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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/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)
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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
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Secondary ID [1]
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TDE-PH-301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Six Minute Walk Distance (6MWD)
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Assessment method [1]
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Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 16, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
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Timepoint [1]
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Baseline and 16 Weeks
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Secondary outcome [1]
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Borg Dyspnea Score
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Assessment method [1]
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The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).
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Timepoint [1]
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Baseline and 16 Weeks
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Secondary outcome [2]
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Clinical Worsening Assessment
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Assessment method [2]
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Definition of clinical worsening required one of the following:
Death (all causes excluding accident)
Transplantation or atrial septostomy
Clinical deterioration as defined by:
Hospitalization as a result of PAH, or
= 20% decrease in 6-minute walk distance from Baseline (or too ill to walk) and a decrease in WHO functional class And
Initiation of new PAH specific therapy (i.e., ERA, PDE5I, prostacyclin).
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Timepoint [2]
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Baseline and 16 Weeks
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Secondary outcome [3]
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Dyspnea-Fatigue Index
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Assessment method [3]
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The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.
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Timepoint [3]
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Baseline and 16 Weeks
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Secondary outcome [4]
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World Health Organization Functional Classification for PAH
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Assessment method [4]
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Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.
Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.
Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.
Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity.
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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Six Minute Walk Distance (6MWD)
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Assessment method [5]
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Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
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Timepoint [5]
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Baseline and 12 weeks
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Secondary outcome [6]
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Six Minute Walk Distance (6MWD)
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Assessment method [6]
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Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
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Timepoint [6]
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Baseline and 8 weeks
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Secondary outcome [7]
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Six Minute Walk Distance (6MWD)
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Assessment method [7]
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Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).
The six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.
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Timepoint [7]
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Baseline and 4 weeks
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Secondary outcome [8]
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Change in Symptoms of PAH From Baseline to Week 16
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Assessment method [8]
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Defined symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain, and orthopnea were assessed at Baseline prior to starting study drug and during the Treatment Phase at Week 16. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom. The outcome data describes the change in severity values from Baseline to Week 16 for each defined symptom of PAH.
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Timepoint [8]
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Baseline and 16 weeks
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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.
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Minimum age
12
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2010
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Sample size
Target
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Accrual to date
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Final
354
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St. Vincent's Hospital - Sydney
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Recruitment hospital [2]
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The Prince Charles Hospital - Brisbane
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Recruitment hospital [3]
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The Alfred Hospital - Melbourne
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Recruitment hospital [4]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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- Sydney
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- Brisbane
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- Melbourne
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Recruitment postcode(s) [4]
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- Perth
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Recruitment outside Australia
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United States of America
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Alabama
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Newcastle
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
United Therapeutics
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Address
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Ethics approval
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00325442
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00325442
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