Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01477333
First received: November 14, 2011
Last updated: February 5, 2013
Last verified: February 2013

November 14, 2011
February 5, 2013
August 2011
March 2013   (final data collection date for primary outcome measure)
Safety and tolerability of the addition of UT-15C SR to Tyvaso [ Time Frame: ≥ 24 weeks ] [ Designated as safety issue: Yes ]
This study consists of a 24-week evaluation period followed by a long term safety follow-up for provision of UT-15C SR until FDA approval or the study is otherwise terminated.
Same as current
Complete list of historical versions of study NCT01477333 on ClinicalTrials.gov Archive Site
  • Change in hemodynamic parameters [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in exercise capacity as measured by the 6- minute walk test (6MWT) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Time to clinical worsening [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • World Health Organization (WHO) functional class [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • N-terminal pro-Brain Natriuretic Peptide (NTproBNP) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®
An Evaluation of the Safety and Efficacy of the Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®

The purpose of this multi-center, open-label, safety and tolerability study is to assess the addition of UT-15C SR to patients currently receiving Tyvaso (treprostinil) inhalation solution. The study will consist of a 24-week evaluation period followed by a long-term safety follow up. Assessments will include: hemodynamics, 6MWT, Borg dyspnea score, NT-proBNP, WHO functional class, and safety assessments.

Eligible patients will have a diagnosis of PAH, currently be receiving Tyvaso, and may be receiving other approved PAH specific oral therapies (ERAs and/or PDE-5 inhibitors, if at a stable dose for ≥ 30 days). At Baseline, subjects will receive the first dose of 0.125 mg UT-15C SR.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
Drug: UT-15C SR
Initiated at 0.125 mg BID, titrated as needed.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
March 2013
March 2013   (final data collection date for primary outcome measure)

Significant inclusion criteria includes:

  1. Subjects will be between 18-75 years
  2. Diagnosis of PAH: Idiopathic; Heritable; Associated with: Collagen vascular disease (CVD), Human immunodeficiency virus (HIV) infection, appetite suppressant or toxin use, or repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years)
  3. Have been receiving Tyvaso for at least 4 weeks (≥ 9 breaths, QID) and require additional therapy

In addition to Tyvaso, subjects may be receiving other approved PAH specific oral therapies (ERAs and/or PDE-5 inhibitors, if at a stable dose).

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01477333
TDE-PH-203
No
United Therapeutics
United Therapeutics
Not Provided
Study Chair: Cindy Madden, MD, MPH Senior Clinical Research Physician
United Therapeutics
February 2013

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