Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00151775
Status:
COMPLETED
Last Update Posted:
2016-06-30
First Post:
2005-09-07
Brief Title:
Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study assesses the efficacy and safety of olmesartan medoxomil in children ages 1-16 with high blood pressure After a 5-week blinded treatment period of up to 5 weeks participants can continue to take olmesartan medoxomil OM for up to an additional 46 weeks
Detailed Description:
This was a randomized multicenter double-blind parallel-group prospective dose-ranging study in subjects 1 to 16 years of age with hypertension Subjects were enrolled into 1 of 3 cohorts based on age and race Subjects 6 to 16 years of age were enrolled into Cohort A Subjects enrolled into Cohort A were stratified by age with approximately half aged 6 to 12 years and the remainder aged 13 to 16 years Approximately 15 of the subjects in Cohort A were to be Black or of African descent When a minimum of 28 Black subjects were randomized into Cohort A enrollment in Cohort B was started Black subjects only 6 to 16 years of age were enrolled into Cohort B For Cohorts A and B body weight of any patient was 20Kg Seated systolic blood pressure SeSBP was 95th percentile for gender and height-for-age or 90th percentile if the patient is diabetic or has glomerular kidney disease or has a family history of hypertension Patients with symptomatic hypertension requiring immediate established therapy or who are above 2 standard deviations SD above the 99th percentile did not participate in the study
Subjects 1 to 5 years of age were enrolled into Cohort C regardless of race Body weight of any patient was 5Kg SeSBP was 95th percentile for gender and height-for-age or 90th percentile if the patient is diabetic or has glomerular kidney disease or has a family history of hypertension Patients on stable doses of concomitant antihypertensive agents including calcium channel blockers andor diuretics only are permitted to enroll Patients with symptomatic hypertension requiring immediate established therapy or who are above 2 SD above the 99th percentile did not participate in the study
The study comprised four periods Period I was a wash-out period from Week -1 to randomization Subjects were randomized to treatment sequences carried through the remainder of the study Period II was a three-week double-blind dose-ranging period for Cohorts A and B beginning at Day 1 and ending at the end of Week 3 In Cohorts A and B subjects received either low-dose or high-dose olmesartan OM once daily In Cohort C Period II was an open-label OM treatment period where all subjects received 03 mgkg OM per day Period III was a double-blind placebo-controlled withdrawal period beginning at Week 4 and ending after 1 or 2 weeks depending on the seated blood pressure measurement at each weekly study visit Subjects either continued their Period II OM regimen or switched to placebo based on the initial randomization scheme Period IV was a 46-week open-label extension period
Subjects 1 to 5 years of age were enrolled into Cohort C regardless of race Body weight of any patient was 5Kg SeSBP was 95th percentile for gender and height-for-age or 90th percentile if the patient is diabetic or has glomerular kidney disease or has a family history of hypertension Patients on stable doses of concomitant antihypertensive agents including calcium channel blockers andor diuretics only are permitted to enroll Patients with symptomatic hypertension requiring immediate established therapy or who are above 2 SD above the 99th percentile did not participate in the study
The study comprised four periods Period I was a wash-out period from Week -1 to randomization Subjects were randomized to treatment sequences carried through the remainder of the study Period II was a three-week double-blind dose-ranging period for Cohorts A and B beginning at Day 1 and ending at the end of Week 3 In Cohorts A and B subjects received either low-dose or high-dose olmesartan OM once daily In Cohort C Period II was an open-label OM treatment period where all subjects received 03 mgkg OM per day Period III was a double-blind placebo-controlled withdrawal period beginning at Week 4 and ending after 1 or 2 weeks depending on the seated blood pressure measurement at each weekly study visit Subjects either continued their Period II OM regimen or switched to placebo based on the initial randomization scheme Period IV was a 46-week open-label extension period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None