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Trial NCT00604383

Resource URI: http://static.linkedct.org/resource/trials/NCT00604383
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/10149>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/13832>
linkedct:brief_title Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
linkedct:condition <http://static.linkedct.org/resource/condition/3876>
linkedct:criteria Inclusion Criteria: - Type 1 or Type 2 diabetes mellitus - 18 years or older - Meet specific requirements for diabetic retinopathy - Free of severe or chronically disabling conditions, except diabetes, diabetic retinopathy and diabetic macular edema - HbA1C <= 13.0% Exclusion Criteria: - History of panretinal photocoagulation for diabetic retinopathy, conditions that might affect the progression of diabetic retinopathy, or unstable angina - Investigators, site personnel directly affiliated with the study and their families - Presence of eye disorders that may affect the progression of diabetic retinopathy or cause vision loss - Presence of medical disorder, cancer, or elevated measurements that could pose a safety risk during the study - Women who are pregnant, breastfeeding, intend to become pregnant, or who are sexually active without using an acceptable method of birth control
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date June 2005
linkedct:enrollment 685 (xsd:int)
linkedct:firstreceived_date January 17, 2008
linkedct:has_dmc No
linkedct:id NCT00604383
linkedct:intervention <http://static.linkedct.org/resource/intervention/22377>
linkedct:intervention <http://static.linkedct.org/resource/intervention/27045>
rdfs:label Trial NCT00604383
linkedct:lastchanged_date January 17, 2008
linkedct:lead_sponsor_agency Eli Lilly and Company
linkedct:location <http://static.linkedct.org/resource/location/138214>
linkedct:nct_id NCT00604383
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title 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.
linkedct:org_study_id 4743
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/7392>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2920>
foaf:page <http://clinicaltrials.gov/show/NCT00604383>
linkedct:phase Phase 3
linkedct:primary_completion_date June 2005
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/40963>
linkedct:secondary_id B7A-MC-MBCM
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/102881>
linkedct:source Eli Lilly and Company
linkedct:start_date March 2001
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary This study is to test whether or not 32mg of ruboxistaurin a day over three years will reduce vision loss associated with diabetic retinopathy.
rdf:type linkedct:trials
linkedct:verification_date January 2008