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An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension (FREEDOM-EXT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01027949
First received: December 4, 2009
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

This study provides UT-15C (treprostinil diethanolamine) to eligible patients with pulmonary arterial hypertension who have completed the TDE-PH-301, TDE-PH-302 or TDE-PH-308 studies. The purpose of this study is to assess the long term safety of UT-15C and to assess the effects of continued treatment with UT-15C on exercise capacity after one year of treatment.


Condition Intervention Phase
Pulmonary Arterial Hypertension
 Drug: Treprostinil diethanolamine
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Six-Minute Walk Distance [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Long-term safety as assessed by clinical laboratories [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Long-term safety as assessed by adverse events [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 900
Study Start Date: May 2006
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open label UT-15C Drug: Treprostinil diethanolamine
Oral sustained release tablet, twice daily

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of TDE-PH-301, TDE-PH-302 or TDE-PH-308

Exclusion Criteria:

  • Premature discontinuation of TDE-PH-301, TDE-PH-302 or TDE-PH-308
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027949

  Show 109 Study Locations
Sponsors and Collaborators
United Therapeutics
Investigators
Study Director: Kevin Laliberte, PharmD United Therapeutics
  More Information

No publications provided

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01027949     History of Changes
Other Study ID Numbers: TDE-PH-304
Study First Received: December 4, 2009
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
 Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013