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| Sponsor: | United Therapeutics |
|---|---|
| Information provided by: | United Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00848939 |
Purpose
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 |
|---|---|---|
|
Systemic Sclerosis |
Drug: treprostinil diethanolamine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: treprostinil diethanolamine |
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Johns Hopkins Scleroderma Center | |
| Baltimore, Maryland, United States, 21224 | |
| United States, Massachusetts | |
| Boston University School of Medicine Rheumatology Arthritis Center | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| University of Michigan Scleroderma Program | |
| Ann Arbor, Michigan, United States, 48016 | |
| Study Director: | Kristan Rollins, PharmD | United Therapeutics |
More Information
| Responsible Party: | Kristan Rollins, PharmD Clinical Research Scientist, United Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00848939 History of Changes |
| Other Study ID Numbers: | TDE-DU-101 |
| Study First Received: | February 19, 2009 |
| Last Updated: | January 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
systemic sclerosis scleroderma pharmacokinetics treprostinil diethanolamine |
|
Scleroderma, Systemic Scleroderma, Diffuse Sclerosis Connective Tissue Diseases Skin Diseases Pathologic Processes |
Treprostinil Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |