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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: February 5, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

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
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: February 5, 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 May 19, 2013