MedTrace Logo

Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)

NCT02125877 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2017-07-25

Study results available
· View outcomes & findings →

Summary

Assessed the new film-coated tablet formulation to the currently approved dispersible tablet formulation with regards to overall safety, Gastrointestinal (GI) tolerability, palatability, satisfaction and compliance

Conditions

  • Chronic Iron Overload Due to Transfusion-dependant Anemias

Interventions

DRUG

Deferasirox dispersible tablet

Deferasirox DT was provided as 125 mg, 250 mg and 500 mg dispersible tablets for oral use.

DRUG

Defearisox film-coated tablet

Deferasirox FCT was provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-08
Primary Completion
2016-02-24
Completion
2016-02-24

Countries

  • United States
  • Argentina
  • Austria
  • France
  • Germany
  • Greece
  • Italy
  • Lebanon
  • Malaysia
  • Mexico
  • Russia
  • Saudi Arabia
  • Spain
  • Thailand
  • United Arab Emirates
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT02125877 on ClinicalTrials.gov