WHO ICTRP trial

A Phase III, Randomised, Double-blind, Multi-centre, Withdrawal Study comparing…

EUCTR2006-003323-37-HU · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2006-003323-37-HU
Public title A Phase III, Randomised, Double-blind, Multi-centre, Withdrawal Study comparing MCI-196 versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia (Incorporating a Randomised 12 Week Open-label Dose Titration Period with MCI-196 or Sevelamer)
Scientific title A Phase III, Randomised, Double-blind, Multi-centre, Withdrawal Study comparing MCI-196 versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia (Incorporating a Randomised 12 Week Open-label Dose Titration Period with MCI-196 or Sevelamer)
Primary sponsor Mitsubishi Tanabe Pharma Corporation
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Countries Hungary;United Kingdom;Germany;Czech Republic;France;Italy;Austria
Conditions Hyperphosphataemia MedDRA version: 8.1 Level: LLT Classification code 10020711 Term: Hyperphosphataemia
Interventions Trade Name: CHOLEBINE® Product Code: MCI-196 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: colestilan CAS Number: 95522-45-5 Current Sponsor code: MCI-196 Other descriptive name: Colestimide Concentration unit: mg…
Registration date Nov 15, 2006
Target size 320
Secondary IDs MCI-196-E07
Registry page clinicaltrialsregister.eu

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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