Pulmonary HypertensionPhase 3NCT00760916
FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
A Phase 3 study testing UT-15C 1 mg, UT-15C 0.25 mg and UT-15C 5 mg in people with Pulmonary Hypertension, run by United Therapeutics at 31 sites in 3 countries.
Trial summary
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- UT-15C 1 mg, UT-15C 0.25 mg and UT-15C 5 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 31 sitesin 3 countries
- Study dates
- Dec 2008to Jan 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 70 years of age, inclusive
- Body weight at least 50 kilograms
- PAH that is either idiopathic/familial; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with HIV.
- 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 or not currently receiving approved PAH therapy.
- Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
- Reliable and cooperative with protocol requirements.
Who cannot join
- 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
Trial locations and contacts
31 sites in 3 countries.
31 sites in 3 countries
United States26 sites
Pulmonary Hypertension Clinic
Aurora, Colorado, 80045
University of Alabama Birmingham
Birmingham, Alabama, 35294
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
University Hospitals of Cleveland
Cleveland, Ohio, 44106
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
University of Texas Southwestern
Dallas, Texas, 75235
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
University of Iowa Health Care
Iowa City, Iowa, 52242
Kansas University Medical Center
Kansas City, Kansas, 66160
West Los Angeles VA Healthcare Center
Los Angeles, California, 90073
University of Minnesota
Minneapolis, Minnesota, 55455
Intermountain Medical Center
Murray, Utah, 84157-7000
Weill Cornell Medical Center
New York, New York, 10021
Columbia Presbyterian Medical Center
New York, New York, 10032
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Maine Medical Center
Portland, Maine, 04102
Lagacy Clinic Northwest
Portland, Oregon, 97210
Mayo Clinic
Rochester, Minnesota, 55902
Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester
Rochester, New York, 14643
UC Davis Medical Center
Sacramento, California, 95817
Washington University Hospital
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
Australia3 sites
Prince Charles Hospital
Brisbane
The Alfred Hospital
Melbourne
St. Vincent's Hospital
Sydney, New South Wales
Mexico2 sites
Instituto Nacional de Cardiologia
Mexico City, Mexico City, 14080
Unidad de Investigacion Clinica en Medicina (UDICEM)
Monterrey
About this study
Official title: FREEDOM DR: An International, Multi-Center, 12-Week, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study Followed by a 12-Week Open-Label Extension Study to Assess the Efficacy, Safety, and Dose Response of UT-15C SR in Subjects With Pulmonary Hypertension
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy treatment. Study visits will occur at 4 week intervals for 12 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. At the end of the first 12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals.
Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).
Read the detailed description
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy treatment. Study visits will occur at 4 week intervals for 12 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. At the end of the first 12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals.
Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).
- Conditions
- Pulmonary Hypertension
- Being tested
- UT-15C 1 mg, UT-15C 0.25 mg, UT-15C 5 mg, Placebo
- Keywords
- Pulmonary Arterial Hypertension
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UT-15C 1 mgDrug
UT-15C 1 mg
UT-15C 0.25 mgDrug
UT-15C 0.25 mg
UT-15C 5 mgDrug
UT-15C 5 mg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
| UT-15C 0.25 mg | Active comparator | UT-15C 0.25 mg Receives: Drug: UT-15C 0.25 mg |
| UT-15C 1 mg | Active comparator | UT-15C 1 mg Receives: Drug: UT-15C 1 mg |
| UT-15C 5 mg | Active comparator | UT-15C 5 mg Receives: Drug: UT-15C 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in six-minute walk distance from Baseline to Week 12
Measured: 12 weeks
Secondary outcomes (12)
Borg Dyspnea Score
Measured: 12 weeks
Clinical Worsening Assessment
Measured: 12 weeks
Dyspnea Fatigue Index
Measured: 12 weeks
Symptoms of PAH
Measured: 12 weeks
World Health Organization (WHO) Functional Class
Measured: 12 weeks
Trough 6-Minute Walk Distance
Measured: 12 weeks
Trough Borg Dyspnea Score
Measured: 12 weeks
Pro-B-type natriuretic peptide (Pro-BNP)
Measured: 12 weeks
Optional hemodynamic parameters
Measured: 12 weeks
Adverse events
Measured: 12 weeks
Clinical Laboratory parameters
Measured: 12 weeks
Electrocardiogram findings
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Study stopped prior to subject enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kevin Laliberte, PharmD, Study director, United Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760916
- Sponsor's protocol ID
- TDE-PH-303
- Status last verified
- Jan 2013
- First submitted
- 25 Sep 2008
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FREEDOM DR: An International, Multi-Center, 12-Week, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study Followed by a 12-Week Open-Label Extension Study to Assess the Efficacy, Safety, and Dose Response of UT-15C SR in Subjects With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT00760916
- Acronym / sponsor ID
- TDE-PH-303
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Arterial Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped prior to subject enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 26 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy treatment. Study visits will occur at 4 week intervals for 12 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. At the end of the first 12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals.
Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).
Detailed description
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy treatment. Study visits will occur at 4 week intervals for 12 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. At the end of the first 12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals.
Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboplacebo |
| UT-15C 0.25 mg | Active comparator | Drug: UT-15C 0.25 mgUT-15C 0.25 mg |
| UT-15C 1 mg | Active comparator | Drug: UT-15C 1 mgUT-15C 1 mg |
| UT-15C 5 mg | Active comparator | Drug: UT-15C 5 mgUT-15C 5 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between 18 and 70 years of age, inclusive
- Body weight at least 50 kilograms
- PAH that is either idiopathic/familial; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with HIV.
- 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 or not currently receiving approved PAH therapy.
- Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UT-15C 1 mgUT-15C 1 mg | Drug | UT-15C 1 mg |
| UT-15C 0.25 mgUT-15C 0.25 mg | Drug | UT-15C 0.25 mg |
| UT-15C 5 mgUT-15C 5 mg | Drug | UT-15C 5 mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in six-minute walk distance from Baseline to Week 12
Time frame: 12 weeks
12 secondary outcomes
Borg Dyspnea Score
Time frame: 12 weeks
Clinical Worsening Assessment
Time frame: 12 weeks
Dyspnea Fatigue Index
Time frame: 12 weeks
Symptoms of PAH
Time frame: 12 weeks
World Health Organization (WHO) Functional Class
Time frame: 12 weeks
Trough 6-Minute Walk Distance
Time frame: 12 weeks
Trough Borg Dyspnea Score
Time frame: 12 weeks
Pro-B-type natriuretic peptide (Pro-BNP)
Time frame: 12 weeks
Optional hemodynamic parameters
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Clinical Laboratory parameters
Time frame: 12 weeks
Electrocardiogram findings
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Laliberte, PharmD study director
United Therapeutics
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing UT-15C 1 mg, UT-15C 0.25 mg and UT-15C 5 mg in people with Pulmonary Hypertension, run by United Therapeutics at 31 sites in 3 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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Australia, Mexico. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in six-minute walk distance from Baseline to Week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2013.