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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01477333 |
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Date of registration:
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14/11/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®
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Scientific title:
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An Evaluation of the Safety and Efficacy of the Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso® |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01477333 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Cynthia Madden, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Associate Director, Medical Development |
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Key inclusion & exclusion criteria
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Significant inclusion criteria includes:
1. Subjects were between 18 to 75 years of age
2. Diagnosis of PAH: Idiopathic; Heritable; Associated with: Collagen vascular disease,
Human immunodeficiency virus (HIV) infection, appetite suppressant or toxin use, or
repaired congenital systemic-to-pulmonary shunts (repaired =5 years)
3. Had been receiving Tyvaso for at least 4 weeks (=9 breaths, 4 times a day [QID]) and
required additional therapy
4. In addition to Tyvaso, subjects may have been receiving other approved PAH specific
oral therapies (ERAs and/or PDE-5 inhibitors, if at a stable dose).
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: UT-15C SR
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Drug: Tyvaso Inhalation Solution
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Primary Outcome(s)
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Change in Hemodynamic Parameter (Cardiac Index) From Baseline to Week 24.
[Time Frame: Baseline and Week 24]
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Change in Hemodynamic Parameter (Pulmonary Vascular Resistance Index) From Baseline to Week 24.
[Time Frame: Baseline and Week 24]
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Change in Hemodynamic Parameter (Cardiac Output) From Baseline to Week 24.
[Time Frame: Baseline and Week 24]
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Change in Hemodynamic Parameters (Arterial and Venous Oxygen Saturation) From Baseline to Week 24.
[Time Frame: Baseline and Week 24]
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Change in Hemodynamic Parameters From Baseline to Week 24.
[Time Frame: Baseline and Week 24]
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Change in Hemodynamic Parameter (Heart Rate) From Baseline to Week 24.
[Time Frame: Baseline and Week 24]
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Secondary Outcome(s)
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Shift From Baseline in World Health Organization (WHO) Functional Class Over the 24-week Treatment Period.
[Time Frame: Baseline and Weeks 4, 8, 12, and 24]
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Time to Clinical Worsening Over the Treatment Period.
[Time Frame: Clinical worsening was assessed continuously from Baseline through each subject's last study visit]
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Change in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Over the 24-week Treatment Period.
[Time Frame: Baseline and Weeks 4, 12, and 24]
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N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Over the 24-week Treatment Period.
[Time Frame: Weeks 12 and 24]
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Secondary ID(s)
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TDE-PH-203
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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