A Dose Response Study of UT-15C SR in Patients With Exercise-Induced Pulmonary Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01104870
First received: January 4, 2010
Last updated: November 6, 2013
Last verified: February 2013

January 4, 2010
November 6, 2013
April 2010
January 2013   (final data collection date for primary outcome measure)
The hemodynamic effect of three different dose regimens of UT-15C SR in patients with exercise-induced PH, as measured by the change in peak total pulmonary resistance index (TPRI) during exercise from Baseline to Week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01104870 on ClinicalTrials.gov Archive Site
  • The effect of three different dose regimens of UT-15C SR on additional hemodynamic parameters. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The effect of different doses of UT-15C SR on the 6-minute walk distance and Borg dyspnea score. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes from Baseline in Symptoms of PH will be summarized and compared between treatment groups. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes from Baseline in WHO functional class will be summarized and compared between treatment groups. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The correlation of treprostinil plasma concentrations and response (i.e., hemodynamics or 6MWD) of UT-15C. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The impact of UT-15C SR on N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentrations. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The safety of three different dose regimens of UT-15C SR will be assessed via physical examination, clinical laboratory and vital sign parameters, 12-lead electrocardiogram (ECG) findings, and pulmonary function tests (PFT), and adverse event reporting. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Dose Response Study of UT-15C SR in Patients With Exercise-Induced Pulmonary Hypertension
A 12-Week, Randomized, Dose Response Study of UT-15C (Treprostinil Diethanolamine) SR in Patients With Exercise-Induced Pulmonary Hypertension

This is a prospective, randomized, parallel group study to assess the hemodynamic effect of three different dose regimens of a sustained release (SR) tablet of UT-15C in patients with exercise-induced pulmonary hypertension (PH), as measured by the change in peak total pulmonary resistance index (TPRI) during exercise from Baseline to Week 12.

Prospective, randomized, parallel group study with two periods: a 10 week, dose titration period, followed by a 2 week, dose maintenance period in patients with exercise-induced PH.

The study population will be randomized into Dose Group 1, Dose Group 2, or an Individual Maximum Tolerated Dose (iMTD) of UT-15C SR by Week 10 and maintained through Week 12. Patients may be either currently receiving an approved oral background therapy for their PH (phosphodiesterase-5 [PDE-5] inhibitor, OR endothelin receptor antagonist [ERA]) (no dual background therapy), or not currently receiving therapy for PH.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Hypertension
Drug: UT-15C
oral
Other Name: treprostinil diethanolamine, sustained release
  • Active Comparator: Dose Group 1
    0.25 mg twice daily
    Intervention: Drug: UT-15C
  • Active Comparator: Dose Group 2
    1.25 mg twice daily
    Intervention: Drug: UT-15C
  • Active Comparator: Dose Group 3
    individual Maximum Tolerated Dose
    Intervention: Drug: UT-15C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients are between 18 and 75 years of age,
  • Have a minimum weight of 40 kg and a Body Mass Index (BMI) < 40 kg/m2,
  • Agree to have right heart catheterization with exercise performed at Baseline and Week 12 (or at the time of early discontinuation), and
  • Have exercise-induced PH defined as a mean pulmonary artery pressure (PAPm) ≥ 30 mmHg during exercise.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01104870
TDE-PH-202
No
United Therapeutics
United Therapeutics
Not Provided
Principal Investigator: Rajan Saggar, MD UCLA Pulmonary Division
United Therapeutics
February 2013

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