NCT03467217

Losartan for the Treatment of Pediatric NAFLD

Losartan for the Treatment of Pediatric NAFLD (STOP-NAFLD): A Phase 2, Randomized, Placebo-Controlled Clinical Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, double masked, placebo-controlled, parallel treatment groups phase 2 trial of losartan for pediatric nonalcoholic fatty liver disease (NAFLD).

Detailed description

Children ages 8-17 years weighing between 70 -149 kilograms will be enrolled and treated with losartan (100 mg orally once per day) or matching placebo for 24 weeks. The hypothesis is that losartan will improve serum alanine aminotransferase (ALT) in children with pediatric NAFLD.

Conditions

• NAFLD - Nonalcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Losartan potassium	Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype
DRUG	Placebo losartan capsule	Matching placebo losartan oral capsule

Timeline

• Start date: 2018-10-02
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2018-03-15
• Last updated: 2021-10-21
• Results posted: 2021-10-21

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study