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Clinical Trial Summary

To examine efficacy and safety after 12-week administration of ASP7991 in secondary hyperparathyroidism patients undergoing hemodialysis


Clinical Trial Description

This study is a multicenter, double-blind, randomized, Cinacalcet hydrochloride-controlled, parallel-group, dose-ascending study. Subjects judged to be eligible will be registered and randomized into either ASP7991 group (receiving ASP7991 and cinacalcet-placebo) or Cinacalcet group (receiving cinacalcet and ASP7991-placebo), and will receive 12-week (84 days) administration of study drug from first dialysis day in a week (treatment period), in a double-blind manner. The dose of the study drugs will be increased every 3 weeks in dose-ascending manner. Follow-up assessment will be performed before starting first dialysis in a week, 1 week (7 days) after the completion of the treatment period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02133404
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 2
Start date March 14, 2014
Completion date November 10, 2014

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