Open-Label Study of Oral Treprostinil in Digital Ulcers - NCT00848107-46202 (Clinical Trial 273446)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy273446.aspx
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| City: |
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Indianapolis |
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State:
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IN |
| Zip Code: |
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46202 |
| Conditions: |
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Systemic Sclerosis |
| Purpose: |
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This open label extension trial will allow ongoing treatment of subjects who participated in
the randomized controlled trials, and will provide long term information about the safety of
treprostinil diethanolamine SR in this patient population
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Eligible subjects who completed assessments for the final visit of the previous
controlled trials and who signed appropriate informed consent are eligible to enroll
in this extension study.
- If a female of childbearing potential, the subject must agree to continue practicing
an acceptable method of birth control (i.e., surgical sterilization, approved
hormonal contraceptives, barrier methods [such as a condom or diaphragm] used with a
spermicide, or an intrauterine device).
Exclusion Criteria:
- Have had any change in clinical status that, in the opinion of the Investigator,
would pose a safety risk for participation in this extension study;
- Have been found to be unable to complete study assessments in the previous controlled
trial;
- Have prematurely discontinued study drug during the previous study |
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| Study is available at: |
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University of Indiana School of Medicine
Indianapolis, IN 46202
United States
Primary Contact:
Kristan Rollins, PharmD
Email: krollins@unither.com
Phone: 919-425-8167 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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