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

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ClinicalTrials.gov Identifier: NCT01027949
Recruitment Status : Active, not recruiting
First Posted : December 9, 2009
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Study Description
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Brief Summary:
This study provides, or continues to provide, UT-15C SR (treprostinil diethanolamine) to eligible patients with pulmonary arterial hypertension who have completed protocols TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, TDE-PH-308 studies or any additional UT-15C SR clinical protocols evaluating subjects with PAH. The study assesses the long term safety of UT-15C and the effect of continued treatment with UT-15C on exercise capacity after one year of treatment.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Treprostinil diethanolamine Phase 3

Detailed Description:
This is an open-label study. Each subject's visit schedule will allow assessments after defined periods of exposure to UT-15C SR (3, 6, 12, 24 and 36 months total exposure). The study will continue with yearly visits beyond 36 months until either UT-15C SR is approved by the appropriate regulatory authorities or the study is discontinued by the sponsor. Therefore, the actual date of each visit will be determined by the date on which the subject first received UT-15C SR (e.g., the date of study drug initiation in TDE-PH- 301, TDE-PH-302, or TDE-PH-308 for subjects who were randomized to active therapy in those trials,and the date of UT-15C SR initiation in this study for subjects who were randomized to placebo in the previous controlled trial). Note that the TDE-PH-202, TDE-PH-203, TDE-PH-205 studies are open-label design and therefore will follow the regimen for subjects receiving UT-15C SR.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension
Study Start Date : May 2006
Estimated Primary Completion Date : December 2020

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treprostinil diethanolamine (UT-15C)
All open will receive active study drug
 Drug: Treprostinil diethanolamine
Oral sustained release tablet, twice or thrice daily. Open label study with active drug, no other intervention arms.


Outcome Measures
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Primary Outcome Measures :
  1. Continued therapy effect on exercise capacity as assessed by a 6-Minute Walk Test [ Time Frame: Once, after one year of therapy with UT-15C SR. ]
  2. Long-term safety as assessed by clinical laboratories [ Time Frame: Performed at each study scheduled visit ]
    After one year exposure to UT-15C clinical laboratorial assessments will occur 1 time/year through study completion until either drug receives regulatory approval in a particular region or the sponsor discontinues the study.

  3. Long-term safety as assessed by adverse events [ Time Frame: Performed monthly during monthly telephone calls ]
    Telephone calls will occur at a minimum 1 time/month through study completion until either drug receives regulatory approval in a particular region or the sponsor discontinues the study.


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Participation in study TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302,TDE-PH-308 or any additional UT-15C SR clinical protocol is required. Subjects must complete all assessments in one of these studies to be eligible.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027949


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Sponsors and Collaborators
United Therapeutics
Investigators
Study Director: Jeff Sigman United Therapeutics
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01027949     History of Changes
Other Study ID Numbers: TDE-PH-304
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017

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