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A Dose Response Study of UT-15C SR in Patients With Exercise-Induced Pulmonary Hypertension - NCT01104870-90024(Clinical Trial 620812)



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City:  Los Angeles
State:  
CA
Zip Code: 90024
Conditions: Pulmonary Hypertension
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.
Study summary: 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.
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.
Study is available at: UCLA Pulmonary Division
Los Angeles, CA 90024
United States

Primary Contact:
Rajeev Saggar, MD
Email: rasaggar@mednet.ucla.edu
Phone: 310-794-2466

Secondary Contact:
Leigh Peterson, PhD
Email: lpeterson@unither.com
Phone: 919-425-8165
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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