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Trial record 1 of 1 for:    NCT01560624
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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
  Purpose
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).

Condition Intervention Phase
Pulmonary Arterial Hypertension Drug: UT-15C (treprostinil diethanolamine) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Time to first clinical worsening event [ Time Frame: From randomization to approximately 4 years ]

Secondary Outcome Measures:
  • Change in 6 minute walk distance [ Time Frame: From Baseline to Week 24 ]

Estimated Enrollment: 850
Study Start Date: July 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo (sugar pill)
Drug: Placebo
Placebo (sugar pill) for three times daily oral administration
Active Comparator: Active
Active UT-15C Sustained release tablet
Drug: UT-15C (treprostinil diethanolamine)
UT-15C sustained release oral tablets for three times daily administration

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560624

  Show 153 Study Locations
Sponsors and Collaborators
United Therapeutics
  More Information

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01560624     History of Changes
Other Study ID Numbers: TDE-PH-310
Study First Received: March 9, 2012
Last Updated: January 24, 2017

Keywords provided by United Therapeutics:
PAH
PH
Clinical Worsening
Freedom
Freedom-Ev
Treprostinil
UT-15C
6 Minute walk test

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents

ClinicalTrials.gov processed this record on September 21, 2017