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This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®), Placebo
Mitsubishi Tanabe Pharma Corporation
Published on BioPortfolio: 2014-08-27T03:37:08-0400
This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07, E08 and E09 studies will allow exposure to MCI-196 for up to 52 weeks
This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexibl...
This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of a single dose of the study drug or placebo ad...
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