Trial of the Early Combination of Oral Treprostinil With Background Oral Monotherapy in Subjects With Pulmonary Arterial Hypertension (FREEDOM-Ev)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by United Therapeutics
Information provided by (Responsible Party):
United Therapeutics Identifier:
First received: March 9, 2012
Last updated: September 2, 2015
Last verified: September 2015

March 9, 2012
September 2, 2015
July 2012
May 2016   (final data collection date for primary outcome measure)
  • Change in 6 minute walk distance [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Time to first clinical worsening event [ Time Frame: From randomization to approximately 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01560624 on Archive Site
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Trial of the Early Combination of Oral Treprostinil With Background Oral Monotherapy in Subjects With Pulmonary Arterial Hypertension
A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects With Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy

This study is an international, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are currently receiving background oral monotherapy for at least 30 days at randomization for their PAH. Study visits will occur in four week intervals for the first 12 weeks, then every 12 weeks thereafter with key measures of efficacy being time to first clinical worsening event and the 6-minute walk test at Week 24. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Patients who complete all required assessments will also be eligible to enter a long-term, open-label, extension study (TDE-PH-311).

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Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: UT-15C (treprostinil diethanolamine)
    UT-15C sustained release oral tablets for three times daily administration
  • Drug: Placebo
    Placebo (sugar pill) for three times daily oral administration
  • Placebo Comparator: Placebo
    Matching placebo (sugar pill)
    Intervention: Drug: Placebo
  • Active Comparator: Active
    Active UT-15C Sustained release tablet
    Intervention: Drug: UT-15C (treprostinil diethanolamine)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2016
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Between 18 and 75 years of age, inclusive
  2. PAH that is idiopathic / heritable, PAH associated with connective tissue disease, HIV infection, repaired congenital systemic-to-pulmonary shunts (repaired > 1 year), or appetite suppressant / toxin use
  3. Receiving one PAH-approved oral therapy at an appropriate dose
  4. Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH

Exclusion Criteria:

  1. Nursing or pregnant
  2. PAH due to conditions other than noted in the above inclusion criteria
  3. History of uncontrolled sleep apnea, severe liver disease, left sided heart disease, uncontrolled systemic hypertension
  4. Use of an investigational drug or device within 30 days of Baseline
18 Years to 75 Years
United States,   Argentina,   Australia,   Austria,   Brazil,   Canada,   Chile,   China,   Denmark,   France,   Germany,   Greece,   India,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Singapore,   Sweden,   Taiwan,   United Kingdom
United Therapeutics
United Therapeutics
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Not Provided
United Therapeutics
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP