Study of Varied Doses to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents with Hypertension

SANKYO PHARMA DEVELOPMENT,0 sites0 target enrollmentAugust 3, 2005

Overview

No summary available.

Registry

who.int

Start Date

August 3, 2005

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

SANKYO PHARMA DEVELOPMENT,

•PATIENTS BETWEEN 6 AND 16 YEARS OLD
•1\) Provide informed consent and agree to attend all visits
•2\) The patient agrees to participate in the study.
•3\) Female or male patient whose age is\> 6 to \<17 years and whose weight is\> 20 kg.
•4\) Adolescents taking oral contraceptives must have been under this therapy for at least 3 months.
•5\) Post\-menarchal women should have a negative result on the pregnancy test
•6\) Hypertension, as defined by a TASps that is equal to or greater than the 95th percentile
•7\) Negative results in the analyzes of hepatitis B and C and negative result for the analysis of antibodies against HIV.
•8\) The patient is not a smoker, or has not smoked during the previous month.
•PATIENTS BETWEEN 1 AND 5 YEARS

•1\) Any unstable medical condition or clinically significant chronic disease.
•2\) Significant clinical illness within the previous 10 days.
•3\) Clinically significant abnormality of the liver system or history of malabsorption or gastrointestinal surgery
•4\) Any of the following clinical laboratory abnormalities: AST / SGOT or ALT / SGPT\> twice the maximum range limit, total bilirubin or direct bilimibin\> twice the maximum limit, creatinine clearance \<25 mL / min / l , 73m2, Hemoglobin \<9 gm / dL, white blood cell count \<3000 / mm ^, platelet count \<1 OO.OOO/mm ^, serum potassium\> maximum limit and serum albumin \<2\.5g / dL.
•5\) Known hypersensitivity to olmesartan medoxomil or its excipients
•6\) The patient has taken a research drug or participated in a research study within 30 days.
•7\) The patient is taking the excluded medications identified in Appendix 8\.
•8\) Consumption of more than 180 mg of caffeine per day and / or the patient can not or does not want to abstain from drinking drinks containing caffeine or xanthine
•9\) Malignant hypertension
•10\) Any condition or reason that causes the investigator to believe that the patient is not suitable for the study.

Not specified