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Sponsored by: |
United Therapeutics |
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Information provided by: | United Therapeutics |
ClinicalTrials.gov Identifier: | NCT00848939 |
This study will assess the pharmacokinetic and safety profile of treprostinil following fixed and escalating doses of treprostinil diethanolamine SR tablets. Open-label, two-part study assessing the pharmacokinetics, safety, and tolerability of oral treprostinil diethanolamine SR. Cohort 1: single 1 mg treprostinil diethanolamine SR dose. Cohort 2: escalating doses of treprostinil diethanolamine SR up to a target dose of 4 mg BID.
Condition | Intervention | Phase |
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Systemic Sclerosis |
Drug: treprostinil diethanolamine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study |
Official Title: | An Evaluation of the Pharmacokinetics and Safety of Fixed and Escalating Doses of Oral Treprostinil Diethanolamine (UT-15C) Sustained Release Tablets in Patients With Systemic Sclerosis |
Estimated Enrollment: | 30 |
Study Start Date: | December 2008 |
Arms | Assigned Interventions |
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treprostinil diethanolamine: Experimental |
Drug: treprostinil diethanolamine
Cohort 1: Single 1 mg treprostinil diethanolamine sustained release tablet dose
Drug: treprostinil diethanolamine
Cohort 2: treprostinil diethanolamine sustained release doses will be escalated up to a target dose of 4 mg BID
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins Scleroderma Center | Not yet recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Cyndi Anderson, MS 410-550-8582 canderson@jhmi.edu | |
Principal Investigator: Fred Wigley, MD | |
United States, Massachusetts | |
Boston University School of Medicine Rheumatology Arthritis Center | Not yet recruiting |
Boston, Massachusetts, United States, 02118 | |
Contact: Fei-Ying Cheong 617-638-4344 fycheong@bu.edu | |
Principal Investigator: Robert Simms, MD | |
United States, Michigan | |
University of Michigan Scleroderma Program | Recruiting |
Ann Arbor, Michigan, United States, 48016 | |
Contact: Terry Thielan 734-936-4009 tthielan@med.umich.edu | |
Principal Investigator: Elena Tishkowski, MD |
Study Director: | Kristan Rollins, PharmD | United Therapeutics |
Responsible Party: | United Therapeutics ( Kristan Rollins, PharmD Clinical Research Scientist ) |
Study ID Numbers: | TDE-DU-101 |
Study First Received: | February 19, 2009 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00848939 History of Changes |
Health Authority: | United States: Food and Drug Administration |
systemic sclerosis scleroderma pharmacokinetics treprostinil diethanolamine |
Skin Diseases Treprostinil Connective Tissue Diseases Scleroderma Scleroderma, Diffuse |
Sclerosis Scleroderma, Systemic Cardiovascular Agents Antihypertensive Agents |
Pathologic Processes Skin Diseases Therapeutic Uses Treprostinil Connective Tissue Diseases Scleroderma, Diffuse |
Sclerosis Scleroderma, Systemic Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |