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| Sponsored by: |
Actelion |
| Information provided by: | Actelion |
| ClinicalTrials.gov Identifier: | NCT00077584 |
Purpose
To date, one clinical trial, RAPIDS-1, was performed in Scleroderma patients with or without digital ulcers at baseline. The RAPIDS-1 study results showed that Bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of this trial is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24 week treatment period.
| Condition | Intervention | Phase |
|
Systemic Sclerosis Scleroderma |
Drug: Bosentan |
Phase III |
| MedlinePlus related topics: | Scleroderma |
| Drug Information available for: | Bosentan |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis |
| Estimated Enrollment: | 180 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | December 2005 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Contacts and Locations![]() |
Show 25 Study Locations |
| Actelion |
| Principal Investigator: | Carol M. Black, MD | Royal Free Hospital, Centre for Rheumatology, London, UK |
| Principal Investigator: | Daniel Furst, MD | UCLA School of Medicine, Los Angeles, CA, USA |
| Principal Investigator: | Joseph H. Korn, MD | Boston University School of Medicine, Boston, MA, USA |
| Principal Investigator: | Marco Matucci, MD | Universita Degli Studi, E Terapia Medica IV, Florence, Italy |
| Principal Investigator: | Maureen Mayes, MD | University of Texas, Medical Branch, 6431 Fannin Street, Houston, TX, USA |
| Principal Investigator: | James Seibold, MD | Robert Wood Johnson Medical School, New Brunswick, NJ, USA |
More Information
| Study ID Numbers: | RAPIDS-2 / AC-052-331 |
| First Received: | February 10, 2004 |
| Last Updated: | February 27, 2006 |
| ClinicalTrials.gov Identifier: | NCT00077584 |
| Health Authority: | United States: Food and Drug Administration |
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