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

Status: Terminated
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 17
Healthy Volunteers: No
View:

• Age 8-17 years at initial screening interview

• Histological evidence of NAFLD with or without fibrosis and a NAFLD activity score (NAS) of ≥3, on a liver biopsy obtained no more than 730 days prior to enrollment.

• Serum ALT at screening ≥ 50 IU/L

Locations
United States
California
University of California, San Diego
San Diego
University of California, San Francisco
San Francisco
Georgia
Emory University
Atlanta
Illinois
Northwestern Univ-Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago
Indiana
Indiana University
Indianapolis
Missouri
St. Louis University
Saint Louis
New York
Columbia University
New York
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Texas
Texas Children's Hospital
Houston
Washington
University of Washington
Seattle
Time Frame
Start Date: October 2, 2018
Completion Date: June 30, 2020
Participants
Target number of participants: 83
Treatments
Active Comparator: Losartan potassium capsule
Dose will be one 50 mg capsule of losartan per day for one week and then increased to two capsules of 50 mg of losartan per day (100 mg total) for 23 weeks patients with baseline weight ≥ 70 kg to <150 kg.
Placebo Comparator: Placebo losartan capsule
Dose will be one 50 mg capsule of placebo losartan per day for one week and then increased to two capsules of 50 mg of placebo losartan per day (100 mg total) for 23 weeks for patients with baseline weight ≥ 70 kg to <150 kg.
Sponsors
Leads: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators: Johns Hopkins University

This content was sourced from clinicaltrials.gov

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