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Trial record 2 of 2 for:    TDE-PH-310

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 January 2017 by United Therapeutics
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01560624
First received: March 9, 2012
Last updated: January 24, 2017
Last verified: January 2017

March 9, 2012
January 24, 2017
July 2012
July 2018   (Final data collection date for primary outcome measure)
Time to first clinical worsening event [ Time Frame: From randomization to approximately 4 years ]
  • Time to first clinical worsening event [ Time Frame: participants will be followed every 12 weeks, at minimum, to assess for signs of clinical worsening for up to 2.5 years ]
  • Change in 6 minute walk distance [ Time Frame: From Baseline to Week 24 ]
Complete list of historical versions of study NCT01560624 on ClinicalTrials.gov Archive Site
Change in 6 minute walk distance [ Time Frame: From Baseline to Week 24 ]
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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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
850
December 2018
July 2018   (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 Screening
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
United States,   Argentina,   Australia,   Austria,   Brazil,   Canada,   Chile,   China,   Denmark,   France,   Germany,   Greece,   India,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Singapore,   Sweden,   Taiwan,   United Kingdom
 
 
NCT01560624
TDE-PH-310
Yes
Not Provided
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United Therapeutics
United Therapeutics
Not Provided
Not Provided
United Therapeutics
January 2017

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