Treatment for Completers of the Study B7A-MC-MBCM
NCT00266695 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 203
Last updated 2016-10-06
Summary
To provide ruboxistaurin treatment to patients who completed the B7A-MC-MBCM study (NCT00604383), and who are felt by the investigator to have the potential to benefit from the ruboxistaurin treatment. Patients must be off study drug for 6 to 18 months from completion of B7A-MC-MBCM before beginning B7A-MC-MBDV. Additional data will be gathered to determine the long-term safety and effect of ruboxistaurin on vision.
Conditions
Interventions
- DRUG
-
Ruboxistaurin
32-milligram (mg) tablet, orally, once daily (QD) for up to 2 years.
Sponsors & Collaborators
-
Chromaderm, Inc.
lead INDUSTRY
Principal Investigators
-
Karl Beutner · Chromaderm, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-01-31
- Primary Completion
- 2008-08-31
- Completion
- 2008-08-31
Countries
- United States
Study Locations
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