Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2/Phase 3

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 and/or 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 0.3 mg/kg 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.
    

Intervention name(s): olmesartan medoxomil; placebo; olmesartan medoxomil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cohorts A and B: 2.5mg to 40mg olmesartan, as a suspension (depending on weight), once daily. Tablets were used to prepare a suspension.
Cohort C: 0.3mg/kg olmesartan ,as a suspension, once daily; Cohorts A, B, C: placebo, once daily; Cohorts A and B: Open label olmesartan medoxomil suspension or tablets 10mg - 40 mg. Tablets were used to prepare the suspension or were given directly.
Cohort C: Open label olmesartan medoxomil suspension 0.3 mg/kg - 0.6 mg/kg
Other intervention name(s): Benicar (olmesartan medoxomil); Benicar (olmesartan medoxomil)
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Treatment of hypertension or high blood pressure in children ages 1-16 years.