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Clinical Trial Details

Trial ID: L0781
Source ID: NCT00926562
Associated Drug: Iopromide (Ultravist)
Title: A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients
Acronym: DIRECT
Status: COMPLETED
Study Results: NO
Results:
Conditions: Kidney Failure, Chronic
Interventions: DRUG: Iopromide (Ultravist)|DRUG: Iodixanol (Visipaque)
Outcome Measures: Primary: Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline., day 3 postreatment | Secondary: Proportion of patients developing acute renal failure., day 30 postreatment|Incidence of a postdose SCr increase ≧25%, a postdose SCr increase ≧1mg/dL, a postdose SCr increase ≧0.5mg/dL, a postdose eGFR decrease ≧25%, days 3
Sponsor/Collaborators: Sponsor: Chinese PLA General Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 592
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2009-02
Completion Date: 2011-05
Results First Posted:
Last Update Posted: 2011-06-27
Locations: Beijing CHAO-YANG Hospital, Beijing, Beijing, 100020, China|General Hospital of Armed Police Forces, Beijing, Beijing, 100039, China|Peking University Third Hospital, Beijing, Beijing, 100191, China|Beijing Shi Jing Shan Hospital, Beijing, Beijing, 10040, China|Beijing Hospital, Beijing, Beijing, 100730, China|Chinese PLA general hospital, Beijing, Beijing, 100853, China|Henan Provincial People's Hospital, Zhengzhou, Henan, 450003, China|The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China|Wuhan Asia Heart Hospital, Wuhan, Hubei, 430022, China|The Second Hospital of Xiangya, Changsha, Hunan, 410013, China|China-Japan Union Hospital of Jilin University, Changchun, Jilin, 130033, China|The First Hospital of Jilin University, Changchun, Jinlin, 130021, China|Shanghai First People's Hospital, Shanghai, Shanghai, 200080, China|Renji Hospital affiliated to Shanghai Jiao Tong University, Shanghai, Shanghai, 200127, China|Changhai Hospital affiliated to the second millitary medical university, Shanghai, Shanghai, 200433, China|Tianjin Chest Hospital, Tianjin, Tianjin, 300051, China|Teda International Cardiovascular Hospital, Tianjin, Tianjin, 300457, China|The Second Hospital Affiliated to Zhejiang University, Hangzhou, Zhejiang, 310009, China|Sir Run Run Shaw Hospital affiliated to Zhejiang, Hangzhou, Zhejiang, 310016, China
URL: https://clinicaltrials.gov/show/NCT00926562

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