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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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19 October 2017 |
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Main ID: |
NCT00887978 |
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Date of registration:
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23/04/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
FREEDOM-C2 |
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Scientific title:
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A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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310 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00887978 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Canada
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France
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Germany
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Ireland
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Israel
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Italy
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Netherlands
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Norway
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Portugal
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Spain
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Sweden
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United Kingdom
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United States
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Contacts
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Name:
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Lewis Rubin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Diego |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- A subject is eligible for inclusion in this study if all of the following criteria
apply:
- Between 18 and 75 years of age, inclusive.
- Body weight at least 40 kg (approximately 90 lbs.)
- PAH that is either idiopathic/heritable; associated with appetite suppressant or toxin
use; associated with collagen vascular disease; associated with repaired congenital
shunts; associated with HIV.
- Currently receiving an approved endothelin receptor antagonist and/or an approved
phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least
the last 30 days.
- Baseline six-minute walk distance (6MWD) between 150-425 meters
- Previous testing (e.g., right heart catheterization, echocardiography) consistent with
the diagnosis of PAH.
- Reliable and cooperative with protocol requirements.
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 Hypertension
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Intervention(s)
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Drug: UT-15C SR
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Drug: Placebo
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Primary Outcome(s)
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6-minute Walk Distance (6MWD)
[Time Frame: Baseline and 16 weeks]
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Secondary Outcome(s)
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N-terminal proBNP (NT-proBNP)
[Time Frame: Baseline and 16 Weeks]
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Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)
[Time Frame: Baseline and 16 Weeks]
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Borg Dyspnea Score
[Time Frame: Baseline and 16 Weeks]
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Clinical Worsening Assessment
[Time Frame: Baseline and 16 Weeks]
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Dyspnea Fatigue Index
[Time Frame: Baseline and 16 Weeks]
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World Health Organization (WHO) Functional Class
[Time Frame: Baseline and 16 Weeks]
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Symptoms of PAH
[Time Frame: Baseline and 16 Weeks]
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Secondary ID(s)
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TDE-PH-308
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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