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)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Hypertension |
Drug: UT-15C 1 mg Drug: UT-15C 0.25 mg Drug: UT-15C 5 mg Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- Change in six-minute walk distance from Baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Borg Dyspnea Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Clinical Worsening Assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Dyspnea Fatigue Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Symptoms of PAH [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- World Health Organization (WHO) Functional Class [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Trough 6-Minute Walk Distance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Trough Borg Dyspnea Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Pro-B-type natriuretic peptide (Pro-BNP) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Optional hemodynamic parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Clinical Laboratory parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Electrocardiogram findings [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
| Study Start Date: | December 2008 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
placebo
|
Drug: Placebo
Placebo
|
|
Active Comparator: UT-15C 0.25 mg
UT-15C 0.25 mg
|
Drug: UT-15C 0.25 mg
UT-15C 0.25 mg
|
|
Active Comparator: UT-15C 1 mg
UT-15C 1 mg
|
Drug: UT-15C 1 mg
UT-15C 1 mg
|
|
Active Comparator: UT-15C 5 mg
UT-15C 5 mg
|
Drug: UT-15C 5 mg
UT-15C 5 mg
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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
Contacts and Locations
Show 31 Study Locations| Study Director: | Kevin Laliberte, PharmD | United Therapeutics |
More Information
No publications provided
| Responsible Party: | Brett Goetz, Associate Manager, Clinical Operations, United Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00760916 History of Changes |
| Other Study ID Numbers: | TDE-PH-303 |
| Study First Received: | September 25, 2008 |
| Last Updated: | January 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by United Therapeutics:
|
Pulmonary Arterial Hypertension |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases Treprostinil Phosphodiesterase 5 Inhibitors |
Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013