NCT02235909

An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension

215 people

54.9%

45.1%

118 womenmiddle line = equal numbers97 men

Phase: PHASE3
Paid for by: Arbor Pharmaceuticals, Inc.
Finished: 2019-11-11
Health conditions: Hypertension
Who could join: Anyone
Ages: 6 Years – 18 Years
Average age: mean 13.4 years
Age 65+: Not reported
Weight (BMI): Not reported
Pregnancy recorded: Not reported
Menopause recorded: Not reported
Results shown by sex: Not split by sex
Race: White 72.1% · Black / African American 25.6% · American Indian / Alaska Native 1.4% · More than one race 0.9% · Asian 0% · Native Hawaiian / Pacific Islander 0% · Not reported 0%

Age limit under 65
Older women were turned away, even though they often take this medicine.
“Maximum age: 18 Years.”
No kidney or liver problems
Women with kidney or liver problems were turned away.
“The subject has any of the following: severe renal impairment (eGFR \<30 mL/min/1.73 m2 by the Schwartz formula); is currently undergoing dialysis treatment; renovascular disease affecting both kidneys or a solitary kidney; severe nephrotic…”
No diabetes
Women with diabetes were turned away.
“The subject is poorly controlled diabetic defined as having a glycosylated hemoglobin value \>8.5% at Screening/Visit 1”
No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“…erthyroidism, Cushing's syndrome), hematologic, immunologic, genito-urinary, or psychiatric disease, cancer, and/or any conditions that would interfere with the health status of the subject through study participation, or would jeopardize s…”
No cancer
Women with current or past cancer were turned away.
“The subject has a diagnosis of malignant or accelerated hypertension”

Study titles and rules are shown in their original English.