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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK061730 | U.S. NIH Grant/Contract | View source |
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Trial stopped for futility
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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
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A multicenter, randomized, double masked, placebo-controlled, parallel treatment groups phase 2 trial of losartan for pediatric nonalcoholic fatty liver disease (NAFLD).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan potassium capsule | Active Comparator | 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 losartan capsule | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan potassium | Drug | Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Alanine Aminotransferase (ALT) From Baseline. | Change ALT value in U/L (24 weeks minus baseline). A negative score indicates improvement. | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gamma-glutamyl Transpeptidase (GGT) Compared to Baseline | Change from baseline in gamma-glutamyl transpeptidase (GGT), measured in U/L. | Baseline and 24 weeks |
| Change in Serum Aspartate Aminotransferase AST at 24 Weeks Compared to Baseline AST |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Body weight less than 70 kg or greater than 150 kg at screening
Significant alcohol consumption or inability to reliably quantify alcohol intake
Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, other known hepatotoxins) for more than 2 consecutive weeks in the past year prior to randomization
New treatment with vitamin E or metformin started in the past 90 days or plans to alter the dose or stop over the next the 24 weeks. A stable dose is acceptable.
Prior or planned bariatric surgery
Uncontrolled diabetes (HbA1c 9.5% or higher)
Presence of cirrhosis on liver biopsy
History of hypotension or history of orthostatic hypotension
Stage 2 Hypertension or >140 systolic or >90 diastolic at screening
Current treatment with any antihypertensive medications including all angiotensin converting enzyme (ACE) inhibitors or aliskiren
Current treatment with potassium supplements or any drug known to increase potassium
Current daily use of nonsteroidal anti-inflammatory drugs (NSAIDs)
Current treatment with lithium
Platelet counts below 100,000 /mm3
Clinical evidence of hepatic decompensation (serum albumin < 3.2 g/dL, international normalized ratio (INR) >1.3, direct bilirubin >1.3 mg/dL, history of esophageal varices, ascites, or hepatic encephalopathy)
Evidence of chronic liver disease other than NAFLD:
Serum alanine aminotransferase (ALT) greater than 300 IU/L
History of biliary diversion
History of kidney disease and/or estimated glomerular filtration rate (eGFR) < than 60 mL/min/1.73 m2 using Schwartz Bedside GFR Calculator for Children isotope dilution mass spectroscopy (IDMS)-traceable
Known Human Immunodeficiency Virus (HIV) infection
Active, serious medical disease with life expectancy less than 5 years
Active substance abuse including inhaled or injected drugs, in the year prior to screening
Pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial, breast feeding
Participation in an investigational new drug (IND) trial in the 150 days prior to randomization
Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study
Inability to swallow capsules
Known allergy to losartan potassium or other angiotensin receptor blocker
Failure of parent or legal guardian to give informed consent or subject to give informed assent
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| Name | Affiliation | Role |
|---|---|---|
| Edward Doo, MD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92103 | United States | ||
| University of California, San Francisco |
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| Label | URL |
|---|---|
| Nonalcoholic Steatohepatitis Clinical Research Network Centers | View source |
| The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | View source |
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This study will comply with the NIH Data Sharing Policy and Results information from this trial will be submitted to ClinicalTrials.gov and a public use database deposited with the NIDDK Central Repository.
Data from this study may be requested from the NIDDK Central Repository (https://www.niddkrepository.org/search/study/) two years after the completion of the primary outcome.
Apply through the NIDDK Central Repository:
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| ID | Title | Description |
|---|---|---|
| FG000 | Losartan | 100 mg losartan once per day |
| FG001 | Placebo | Matching placebo, taken once per day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2019 |
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Participants, investigators, clinical staff, and data monitoring committee will not have knowledge of the interventions assigned to individual participants.
| Placebo losartan capsule | Drug | Matching placebo losartan oral capsule |
|
Change from baseline in serum aspartate aminotransferase, measured in U/L. |
| Baseline and 24 weeks |
| Relative Change in Serum Alanine Aminotransferase (ALT) Compared to Baseline ALT | Relative change from baseline in serum ALT, measured in percentage of change. | Baseline and 24 weeks |
| Change in ALT at 12 Weeks Compared to Baseline ALT | Change from baseline in ALT at 12 weeks, measured in U/L. | Baseline and 12 weeks |
| Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Compared to Baseline. | Homeostasis Model Assessment of Insulin Resistance Index (HOMA-IR) measures insulin resistance, calculated by fasting insulin (umol/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance. | Baseline and 24 weeks |
| Change in Weight at 24 Weeks Compared to Baseline | Change from baseline in weight, measured in kg. | Baseline and 24 weeks |
| Change in Body Mass Index (BMI) at 24 Weeks Compared to Baseline. | Change from baseline in BMI, measured in kg/m^2. | Baseline and 24 weeks |
| Change in Waist Circumference at 24 Weeks Compared to Baseline | Change from baseline in waist circumference, measured in centimeters. | Baseline and 24 weeks |
| Change in Waist-to-hip Ratio at 24 Weeks Compared to Baseline | Change from baseline in waist-to-hip ratio, measured as the circumference of the waist in centimeters divided by the circumference of the hips in centimeters. | Baseline and 24 weeks |
| Change in Pediatric Quality of Life Inventory (PedsQOL) Physical Health Score at 24 Weeks Compared to Baseline | Pediatric Quality of Life Inventory (PedsQOL) version 4.0 is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Physical Health Summary Score =Physical Functioning Scale Score. The outcome is 24-week change from baseline in PedsQOL Physical Health Score, where higher values indicate improvement in quality of life. | Baseline and 24 weeks |
| Frequency of Adverse Events Over 24 Weeks | Numbers of adverse events reported over 24 weeks. | Baseline and 24 weeks |
| Change in Total Cholesterol at 24 Weeks Compared to Baseline | Change from baseline in total cholesterol, measured in mg/dL | Baseline and 24 weeks |
| Change in Triglycerides at 24 Weeks Compared to Baseline | Change from baseline in triglycerides, measured in mg/dL | Baseline and 24 weeks |
| Change in HDL Cholesterol at 24 Weeks Compared to Baseline | Change from baseline in HDL cholesterol, measured in mg/dL | Baseline and 24 weeks |
| Change in LDL Cholesterol at 24 Weeks Compared to Baseline | Change from baseline in LDL cholesterol, measured in mg/dL | Baseline and 24 weeks |
| Change in Pediatric Quality of Life Inventory (PedsQOL) Psychosocial Health Score at 24 Weeks Compared to Baseline | Pediatric Quality of Life Inventory (PedsQOL) version 4.0 is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Psychosocial Health Summary Score = Sum of items over the number of items answered in the Emotional, Social, and School Functioning Scales. The outcome is 24-week change from baseline in PedsQOL Psychosocial Health Score, where higher values indicate improvement in quality of life. | Baseline and 24 weeks |
| San Francisco |
| California |
| 94143 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern Univ-Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611-2605 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| St. Louis University | St Louis | Missouri | 63104 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Losartan potassium: Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype |
| BG001 | 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. Placebo losartan capsule: Matching placebo losartan oral capsule |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Alanine aminotransferase | Mean | Standard Deviation | U/L |
| |||||||||||||||
| Aspartate aminotransferase | Mean | Standard Deviation | U/L |
| |||||||||||||||
| Alkaline phosphate | Mean | Standard Deviation | U/L |
| |||||||||||||||
| y-Glutamyltransferase | Mean | Standard Deviation | U/L |
| |||||||||||||||
| Total bilirubin | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| Direct bilirubin | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| Total cholesterol | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| High-density lipoprotein | Mean | Standard Deviation | mg/uL |
| |||||||||||||||
| Low-density lipoprotein | Mean | Standard Deviation | mg/uL |
| |||||||||||||||
| Triglycerides | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| Fasting serum glucose | Median | Inter-Quartile Range | mg/dL |
| |||||||||||||||
| Insulin | Median | Inter-Quartile Range | umol/mL |
| |||||||||||||||
| Homeostasis model assessment (HOMA) score of insulin resistance | Insulin Resistance Index (HOMA-IR) measures insulin resistance, calculated by fasting insulin (umol/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance | Median | Inter-Quartile Range | mg/dL x umol/mL/405 |
| ||||||||||||||
| Hemoglobin A1c | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body-mass index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Mid arm circumference | Mean | Standard Deviation | cm |
| |||||||||||||||
| Waist circumference | Median | Standard Deviation | cm |
| |||||||||||||||
| Hip circumference | Median | Standard Deviation | cm |
| |||||||||||||||
| Waist to hip ratio | Mean | Standard Deviation | ratio |
| |||||||||||||||
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| Pulse | Mean | Standard Deviation | beats per minute |
| |||||||||||||||
| Breath rate | Mean | Standard Deviation | breaths/minute |
| |||||||||||||||
| Hemoglobin | Mean | Standard Deviation | g/dL |
| |||||||||||||||
| Hematocrit | Mean | Standard Deviation | percentage of hematocrit |
| |||||||||||||||
| MCV | Mean | Standard Deviation | fL |
| |||||||||||||||
| White blood cell count (WBC) | Mean | Standard Deviation | 10^3 cells/uL |
| |||||||||||||||
| Red blood cell count (RBC) | Mean | Standard Deviation | million cells/uL |
| |||||||||||||||
| Neutrophils | Mean | Standard Deviation | cells/uL |
| |||||||||||||||
| Lymphocytes | Mean | Standard Deviation | cells/uL |
| |||||||||||||||
| Monocytes | Median | Standard Deviation | cells/uL |
| |||||||||||||||
| Eosinophils | Median | Standard Deviation | cells/uL |
| |||||||||||||||
| Basophils | Mean | Standard Deviation | cells/uL |
| |||||||||||||||
| Platelet | Median | Standard Deviation | 1000 cells/mm^3 |
| |||||||||||||||
| Sodium | Median | Standard Deviation | mEq/L |
| |||||||||||||||
| Potassium | Median | Standard Deviation | mEq/L |
| |||||||||||||||
| Chloride | Median | Standard Deviation | mEq/L |
| |||||||||||||||
| Bicarbonate | Median | Standard Deviation | mEq/L |
| |||||||||||||||
| Calcium | Median | Standard Deviation | mEq/L |
| |||||||||||||||
| Blood urea nitrogen | Median | Standard Deviation | mg/dL |
| |||||||||||||||
| Creatinine | Median | Standard Deviation | mg/dL |
| |||||||||||||||
| Estimated glomerular filtration rate (eGFR) | Mean | Standard Deviation | mL/min/1.73m^2 |
| |||||||||||||||
| Prothrombin time | Mean | Standard Deviation | seconds |
| |||||||||||||||
| International normalized ratio (INR) | Mean | Standard Deviation | ratio |
| |||||||||||||||
| Uric acid | Median | Standard Deviation | mg/dL |
| |||||||||||||||
| C-reactive protein | Mean | Standard Deviation | mg/L |
| |||||||||||||||
| Time from liver biopsy | Mean | Standard Deviation | years |
| |||||||||||||||
| Nonalcoholic fatty liver disease (NAFLD) activity score | The Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) is a composite score equal to the sum of the steatosis grade (0-3), lobular inflammation grade (0-3), and hepatocellular ballooning grade (0-2), from centralized pathologist scoring of liver biopsies. The overall scale of the NAS is 0-8, with higher scores indicating more severe disease. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Steatohepatitis Diagnosis | Steatohepatitis diagnosis is based on central pathologists' review of liver biopsies. NAFLD, but not NASH was defined by at least 5% steatosis with or without inflammation but without ballooning injury. Borderline zone 3 pattern and borderline zone 1 pattern steatohepatitis had some but not all features of definite steatohepatitis, usually consisting of steatosis, inflammation, and fibrosis without ballooning. Definite steatohepatitis was defined by the presence of macrovesicular steatosis, inflammation, and hepatocellular ballooning. Definite steatohepatitis is considered a worse outcome. | Count of Participants | Participants |
| |||||||||||||||
| Fibrosis stage | The amount of fibrosis is based on central pathologist grading of liver biopsies: 0=no fibrosis present; 1a=mild, zone 3 perisinusoidal fibrosis, 1b=moderate, zone 3, perisinusoidal fibrosis, 1c=portal/periportal fibrosis only, 2=zone 3 and periportal fibrosis, any combination, 3=bridging fibrosis. Fibrosis stages 1a, 1b, 1c recoded as 1, so the possible range of values for fibrosis stage was 0-3. Higher stage indicates worse outcome. | Count of Participants | Participants |
| |||||||||||||||
| Hepatocellular ballooning grade | Hepatocellular ballooning grade based on pathologists' centralized scoring of liver biopsies. Hepatocellular ballooning grade scored as 0=none, 1=few ballooned hepatocytes, and 2=many ballooned hepatocytes. Higher values indicate worse outcome. | Count of Participants | Participants |
| |||||||||||||||
| Steatosis | Steatosis score is based on central pathologists' grading of liver biopsies: 0=<5% steatosis; 1=5-33% steatosis, 2=34-66% steatosis, 3=>66% steatosis. Higher values indicate worse outcome. | Count of Participants | Participants |
| |||||||||||||||
| Lobular inflammation | The amount of lobular inflammation is based on central pathologists' grading of liver biopsies, and combines mononuclear, fat granulomas, and polymorphonuclear (pmn) foci: 0=none; 1=<2 under 20x magnification, 2=2-4 under 20x magnification, 3=>4 under 20x magnification. Lobular inflammation score has a possible range of 0 to 3. Higher values indicating a worse outcome. | Count of Participants | Participants |
| |||||||||||||||
| Portal inflammation | The amount of portal inflammation is based on central pathologists' grading of liver biopsies: 0=none; 1=mild, 2=more than mild. Higher values indicate worse outcome. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Serum Alanine Aminotransferase (ALT) From Baseline. | Change ALT value in U/L (24 weeks minus baseline). A negative score indicates improvement. | Results based on complete case analysis. | Posted | Mean | Standard Deviation | U/L | Baseline and 24 weeks |
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| Secondary | Change in Gamma-glutamyl Transpeptidase (GGT) Compared to Baseline | Change from baseline in gamma-glutamyl transpeptidase (GGT), measured in U/L. | Posted | Mean | Standard Deviation | U/L | Baseline and 24 weeks |
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| Secondary | Change in Serum Aspartate Aminotransferase AST at 24 Weeks Compared to Baseline AST | Change from baseline in serum aspartate aminotransferase, measured in U/L. | Posted | Mean | Standard Deviation | U/L | Baseline and 24 weeks |
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| Secondary | Relative Change in Serum Alanine Aminotransferase (ALT) Compared to Baseline ALT | Relative change from baseline in serum ALT, measured in percentage of change. | Posted | Mean | Standard Deviation | percentage of change | Baseline and 24 weeks |
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| Secondary | Change in ALT at 12 Weeks Compared to Baseline ALT | Change from baseline in ALT at 12 weeks, measured in U/L. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 12 weeks |
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| Secondary | Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Compared to Baseline. | Homeostasis Model Assessment of Insulin Resistance Index (HOMA-IR) measures insulin resistance, calculated by fasting insulin (umol/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance. | Posted | Mean | Standard Deviation | mg/dL x uU/mL/405 | Baseline and 24 weeks |
|
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| Secondary | Change in Weight at 24 Weeks Compared to Baseline | Change from baseline in weight, measured in kg. | Posted | Mean | Standard Deviation | kg | Baseline and 24 weeks |
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| Secondary | Change in Body Mass Index (BMI) at 24 Weeks Compared to Baseline. | Change from baseline in BMI, measured in kg/m^2. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline and 24 weeks |
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| Secondary | Change in Waist Circumference at 24 Weeks Compared to Baseline | Change from baseline in waist circumference, measured in centimeters. | Posted | Mean | Standard Deviation | cm | Baseline and 24 weeks |
|
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| Secondary | Change in Waist-to-hip Ratio at 24 Weeks Compared to Baseline | Change from baseline in waist-to-hip ratio, measured as the circumference of the waist in centimeters divided by the circumference of the hips in centimeters. | Posted | Mean | Standard Deviation | ratio | Baseline and 24 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Pediatric Quality of Life Inventory (PedsQOL) Physical Health Score at 24 Weeks Compared to Baseline | Pediatric Quality of Life Inventory (PedsQOL) version 4.0 is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Physical Health Summary Score =Physical Functioning Scale Score. The outcome is 24-week change from baseline in PedsQOL Physical Health Score, where higher values indicate improvement in quality of life. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 24 weeks |
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| Secondary | Frequency of Adverse Events Over 24 Weeks | Numbers of adverse events reported over 24 weeks. | Posted | Number | adverse events | Baseline and 24 weeks |
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| Secondary | Change in Total Cholesterol at 24 Weeks Compared to Baseline | Change from baseline in total cholesterol, measured in mg/dL | Posted | Mean | Standard Deviation | mg/dL | Baseline and 24 weeks |
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| Secondary | Change in Triglycerides at 24 Weeks Compared to Baseline | Change from baseline in triglycerides, measured in mg/dL | Posted | Mean | Standard Deviation | mg/dL | Baseline and 24 weeks |
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| Secondary | Change in HDL Cholesterol at 24 Weeks Compared to Baseline | Change from baseline in HDL cholesterol, measured in mg/dL | Posted | Mean | Standard Deviation | mg/dL | Baseline and 24 weeks |
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| Secondary | Change in LDL Cholesterol at 24 Weeks Compared to Baseline | Change from baseline in LDL cholesterol, measured in mg/dL | Posted | Mean | Standard Deviation | mg/dL | Baseline and 24 weeks |
|
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| Secondary | Change in Pediatric Quality of Life Inventory (PedsQOL) Psychosocial Health Score at 24 Weeks Compared to Baseline | Pediatric Quality of Life Inventory (PedsQOL) version 4.0 is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Psychosocial Health Summary Score = Sum of items over the number of items answered in the Emotional, Social, and School Functioning Scales. The outcome is 24-week change from baseline in PedsQOL Psychosocial Health Score, where higher values indicate improvement in quality of life. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 24 weeks |
|
Adverse event data were collected over a time period of 36 weeks.
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Losartan | 100 mg losartan once per day | 0 | 43 | 0 | 43 | 28 | 43 |
| EG001 | Placebo | Matching placebo, taken once per day | 0 | 40 | 4 | 40 | 25 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Surgical and medication procedures - Other, bilateral knee surgery | Surgical and medical procedures | CTCAE (5.0) | Non-systematic Assessment | Bilateral knee surgery for genu valgum |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Flu like symptoms | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder, other - knee injury, pain, bursitis | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Middle ear inflammation | Ear and labyrinth disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder, other-slipped capital femoral epiphysis (SCFE) | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Otitis externa | Ear and labyrinth disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Surgical and medical procedures - Other, Rhinoseptoplasty | Surgical and medical procedures | CTCAE (5.0) | Non-systematic Assessment |
| |
| Rash, pustular | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Sinusitus | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Sore throat | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Viremia | Infections and infestations | CTCAE (5.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Wilson | Johns Hopkins Bloomberg School of Public Health | 410-955-0719 | lwilson9@jhu.edu |
| May 26, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Parental Permission Form | Feb 18, 2019 | May 26, 2021 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Child Assent Form | May 21, 2018 | May 26, 2021 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: HIPAA Authorization Form | May 21, 2018 | May 26, 2021 | ICF_003.pdf |
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Borderline Zone 3 |
|
| Borderline Zone 1 |
|
| Definite steatohepatitis |
|
| Stage 1 |
|
| Stage 2 |
|
| Stage 3 |
|
| 1 - Few |
|
| 2 - Many |
|
| 34-66% |
|
| >66% |
|
| 2-4 under 20x magnification |
|
| >4 under 20x magnification |
|
| Mild |
|
| More than mild |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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