Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension

Daiichi Sankyo Pharma Development0 sites362 target enrollmentJuly 28, 2015

Overview

No summary available.

Registry

who.int

Start Date

July 28, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Daiichi Sankyo Pharma Development

•Inclusion Criteria for Subjects 6 to 16 Years of Age
•1\. Provided informed consent and agreed to attend all clinic visits. (An informed consent form \[ICF] was approved by the IRB/IEC and was signed by the parent/legal guardian.)
•2\. Subject assented to the study.
•3\. Female or male subject who was 6 years to \< 17 years of age and weighing 20 kg. (Note, a subject was considered 16 years of age until the day before their 17th birthday at the Screening Visit.)
•4\. Adolescent females taking oral contraceptives had to be on therapy for at least 3 months before Screening. Not applicable to male subjects.
•5\. Post\-menarchal females had to have a negative urine pregnancy test result within 72 hours prior to receiving study drug. These subjects were not to become pregnant for the duration of the study and were to use acceptable contraception. Not applicable to male subjects.
•6\. Hypertension defined as a SeSBP measuring at or above the 95th percentile (90th percentile for diabetics, subjects with glomerular kidney disease, or subjects with a family history of hypertension) for age, gender, and height while off any antihypertension medication. Subjects had to meet this requirement by Visit 1\.2\.
•7\. Negative hepatitis B and C tests and a negative human immunodeficiency virus (HIV) antibody test.
•8\. Subject was a non\-smoker or had not smoked for the past month.
•Inclusion Criteria for Subjects 1 to 5 Years of Age

•1\. Had any clinically relevant unstable medical condition or chronic disease other than those associated with hypertension.
•2\. Had significant clinical illness within 10 days prior to receiving the first dose of study medication (Day 1, Visit 2\.0 of Period II).
•3\. Had clinically relevant abnormality of the hepatic system or a history of malabsorption or previous gastrointestinal surgery that could affect drug absorption or metabolism.
•4\. Had any of the following clinical laboratory abnormalities:
•\-an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that was \> 2 times the upper limit of the reference range;
•\-a total bilirubin or direct bilirubin that was \> 2 times the upper limit of the reference range;
•\-a creatinine clearance that was \< 25 mL/min/1\.73m^2 (calculated using Modified Schwartz formula to estimate glomerular filtration rate \[GFR]);
•\-a hemoglobin that was \< 9 g/dL;
•\-a white blood cell (WBC) count that was \< 3000/mm^3;
•\-a platelet count that was \< 100,000/ mm^3;