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NCT01913470 · ClinicalTrials.gov registry record · Phase 2
Study of Losartan in the Treatment of NAFLD in Children
A Phase 2 study, sponsored by Miriam Vos, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01913470 is a Phase 2 study that has completed, run by Miriam Vos, MD. The registered enrollment target is 12 participants.
The verdict
NCT01913470, a Phase 2 study, has completed, sponsored by Miriam Vos, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease among children and is closely associated with obesity and the metabolic syndrome. NAFLD increases risk of mortality and natural history studies of adults show that NAFLD is an independent risk factor for cardiovascular disease. Pediatric NAFLD is particularly concerning from a public health standpoint, as it represents an early and possibly more aggressive form of the disease. Currently there is no effective treatment for pediatric NAFLD. Losartan is an orally-administered angiotensin II receptor antagonist which is currently on the market to treat high blood pressure. The renin-angiotensin-aldosterone (RAA) system has been shown to be important in many disease states including renal disease, cardiovascular disease, and NAFLD. Angiotensin antagonists are a class of medications that has been proposed as a novel treatment of NAFLD in part because they would treat both the factors increasing cardiovascular (CVD) risks as well as potentially improve steatosis, fibrosis and hepatic inflammation. This study is a randomized, double-blinded, placebo-controlled pilot study to evaluate whether 8 weeks of Losartan will decrease inflammatory markers among children ages 12-19 with a current diagnosis of NAFLD. Efficacy will be assessed by improvement in alanine aminotransferase (ALT) from baseline. Secondary endpoints will include aspartate aminotransferase (AST), cytokeratin 18 levels, and fasting triglyceride levels among others. Safety will be assessed by the recording of adverse events, clinical laboratory parameters, vital signs and physical examinations.
Interventions
- DRUG Losartan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01913470
The ClinicalTrials.gov registry entry for NCT01913470 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Miriam Vos, MD, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Losartan is the first listed.
NCT01913470 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01913470 about?
NCT01913470 is a clinical study titled "Study of Losartan in the Treatment of NAFLD in Children". Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease among children and is closely associated with obesity and the metabolic syndrome. NAFLD increases risk of mortality and natural history studies of adults show that NAFLD is an independent risk factor for cardiovascular diseas...
What is the current status of trial NCT01913470?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2013-07. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01913470?
The interventions under investigation include: Losartan (DRUG).
Who is sponsoring clinical trial NCT01913470?
This trial is sponsored by Miriam Vos, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
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