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
  Purpose

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.


Condition Intervention Phase
Pulmonary Hypertension
Drug: UT-15C
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-Week, Randomized, Dose Response Study of UT-15C (Treprostinil Diethanolamine) SR in Patients With Exercise-Induced Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: April 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dose Group 1
0.25 mg twice daily
Drug: UT-15C
oral
Other Name: treprostinil diethanolamine, sustained release
Active Comparator: Dose Group 2
1.25 mg twice daily
Drug: UT-15C
oral
Other Name: treprostinil diethanolamine, sustained release
Active Comparator: Dose Group 3
individual Maximum Tolerated Dose
Drug: UT-15C
oral
Other Name: treprostinil diethanolamine, sustained release

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104870

Locations
United States, California
UCLA Division of Pulmonary and Critical Care
Los Angeles, California, United States, 90095
Sponsors and Collaborators
United Therapeutics
Investigators
Principal Investigator: Rajan Saggar, MD UCLA Pulmonary Division
  More Information

No publications provided

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01104870     History of Changes
Other Study ID Numbers: TDE-PH-202
Study First Received: January 4, 2010
Last Updated: November 6, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 30, 2014