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TONIC: Treatment of NAFLD in Children
NCT00063635Phase 3Completed
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases
- Start
- Sep 2005
- Primary completion
- Sep 2009
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in non-alcoholic fatty liver disease (NAFLD) comparing Metformin, Vitamin E and Placebo (3 arms). Primary endpoint: Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L at 96 weeks. Started Sep 2005; status: completed.
02
Drugs
metforminvitamin e
03
Conditions
non-alcoholic fatty liver disease (NAFLD)
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