Trials / Completed
CompletedNCT00604383
Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
Phase 3, Multicenter,Parallel,Randomized Dbl-masked,Placebo-controlled Study of the Effects of 32 mg/dy Ruboxistaurin Vision Loss in Patients With Type 1 or Type 2 Diabetes Mellitus and an Early Treatment Diabetic Retinopathy Study Level Between 47A and 53E.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 685 (actual)
- Sponsor
- Chromaderm, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is to test whether or not 32 milligrams (mg) of ruboxistaurin a day over three years will reduce vision loss associated with diabetic retinopathy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ruboxistaurin | 32-mg tablet, orally, daily, up to 42 months |
| DRUG | placebo | 1 tablet, orally, daily, up to 42 months |
Timeline
- Start date
- 2001-03-01
- Primary completion
- 2005-06-01
- Completion
- 2005-06-01
- First posted
- 2008-01-30
- Last updated
- 2016-10-06
- Results posted
- 2016-01-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00604383. Inclusion in this directory is not an endorsement.