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A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia

NCT00416520 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2026-01-08

Study results available
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Summary

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, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

Conditions

Interventions

DRUG

MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)

3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind

DRUG

Placebo

3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

DRUG

Another phosphate binder (Sevelamer)

Current approved dosing recommendations for 12 weeks

Sponsors & Collaborators

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Professor · Information at Mitsubishi Pharma Europe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Australia
  • Austria
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00416520 on ClinicalTrials.gov