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

Tracking Information

First Received Date ^ICMJE

December 4, 2009

Last Updated Date

February 28, 2013

Start Date ^ICMJE

May 2006

Estimated Primary Completion Date

December 2020 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01027949 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Arterial Hypertension

Intervention ^ICMJE

Drug: Treprostinil diethanolamine

Oral sustained release tablet, twice daily

Study Arm (s)

Experimental: Open label UT-15C

Intervention: Drug: Treprostinil diethanolamine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

900

Completion Date

Not Provided

Estimated Primary Completion Date

December 2020 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Austria, Belgium, Canada, France, Germany, India, Ireland, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Spain, Sweden, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01027949

Other Study ID Numbers ^ICMJE

TDE-PH-304

Has Data Monitoring Committee

Not Provided

Responsible Party

United Therapeutics

Study Sponsor ^ICMJE

United Therapeutics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Kevin Laliberte, PharmD

United Therapeutics

Information Provided By

United Therapeutics

Verification Date

February 2013

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

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