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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00325403 |
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Date of registration:
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11/05/2006 |
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Primary sponsor: |
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Public title:
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FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
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Scientific title:
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A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison 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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May 2006 |
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Target sample size:
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315 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00325403 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Austria
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Belgium
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Canada
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China
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France
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India
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Israel
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Italy
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Mexico
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Netherlands
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Poland
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Puerto Rico
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United States
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Contacts
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Name:
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Kevin Laliberte, PharmD |
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Address:
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Telephone:
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Email:
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Affiliation:
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United Therapeutics |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Between 12 and 75 years of age, inclusive.
- Body weight at least 40 kg with a Body Mass Index < 45
- PAH that is either idiopathic/familial; associated with repaired congenital
systemic-to-pulmonary shunts (repaired = 5 years); associated with collagen vascular
disease; associated with HIV.
- Previous testing (e.g., right heart catheterization, echocardiography) consistent
with the diagnosis of PAH.
- Reliable and cooperative with protocol requirements.
Exclusion Criteria:
- Nursing or pregnant.
- Currently receiving an endothelin receptor antagonist, a phosphodiesterase-5
inhibitor, or prostacyclin within 30 days of Baseline.
- PAH due to conditions other than noted in the above inclusion criteria.
- History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart
disease, uncontrolled systemic hypertension, or parenchymal lung disease.
- Use of an investigational drug within 30 days of Baseline.
Age minimum:
12 Years
Age maximum:
75 Years
Gender:
Both
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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: Oral treprostinil (UT-15C) Sustained Release Tablets
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Other: Placebo
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Primary Outcome(s)
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Change in 6-minute walk distance from Baseline to Week 12
[Time Frame: 12 Weeks]
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Secondary Outcome(s)
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Adverse events
[Time Frame: Continuously over 12 Weeks]
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Borg dyspnea score
[Time Frame: 4 Weeks]
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Clinical laboratory parameters
[Time Frame: 4-8 Weeks]
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Clinical Worsening Assessment
[Time Frame: 12 Weeks]
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Dyspnea-Fatigue Index
[Time Frame: 4 Weeks]
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Electrocardiogram findings
[Time Frame: 12 Weeks]
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Symptoms of PAH
[Time Frame: 4 Weeks]
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World Health Organization Functional Classification for PAH
[Time Frame: 4 Weeks]
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Secondary ID(s)
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TDE-PH-302
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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