MedTrace Logo

A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia

NCT00451295 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2011-11-15

No results posted yet for this study

Summary

This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 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

DRUG

Placebo

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

Sponsors & Collaborators

  • Mitsubishi Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Professor · Information at Mitsubishi Pharma Europe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Czechia
  • France
  • Germany
  • Italy
  • North Macedonia
  • Poland
  • Serbia
  • 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 NCT00451295 on ClinicalTrials.gov