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

Not Applicable

• Conditions: -I10 Essential (primary) hypertension; Essential (primary) hypertension; I10

• Registration Number: PER-008-05
• Lead Sponsor: SANKYO PHARMA DEVELOPMENT,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-03
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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) Provide informed consent and agree to attend all visits
2) Female or male patient whose age is> I year to <6 years and whose weight is> 5 kg.
3) Hypertension, as defined by a TASps that is equal to or greater than the 95th percentile
4) Negative results in the analyzes of hepatitis B and C and negative result for the analysis of antibodies against HIV.
5) The patient must not be a smoker.

Exclusion Criteria

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.
11) The patient requires treatment for hypertension with more than 2 medications.
12) History of congestive heart failure, obstructive valvular disease or cardiomyopathy.
13) Coarctation of the uncorrected aorta, stenosis of the bilateral renal artery or stenosis of the unilateral renal artery in a solitary kidney.
14) Kidney transplant within the last 6 months or the patient is not on a stable therapy for rejection for at least 3

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Change of the base percentile of the Systolic Blood Pressure (TASps): Measurements of Blood Pressure during period II (Period of response to the dose).<br>Measure:Efficacy of Olemsartan medoxomil: Change in the TASps with the valley concentration from the baseline of the study.<br>Timepoints:Day 1 and weeks 1, 2 and 3.<br>