Clinical trial NCT00151775: Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure
Official title: Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypertension
Keywords: Treatment of hypertension or high blood pressure in children ages 1-16 years.
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 362
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* The patient's seated systolic BP (SeSBP) will be greater than or equal to 95th percentile for gender and height-for- age, or greater than or equal to 90th percentile if the patient is diabetic, or has glomerular kidney disease, or has a family history of hypertension.
* Negative for hepatitis B and C
* Negative for HIV

Exclusion Criteria:

* Patient should not have serious other conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patient in the trial.
* Known sensitivity to olmesartan medoxomil
* Taking prohibited medication
* Consumed greater than 180 mg of caffeine daily
* Malignant hypertension
* History of congestive heart failure, cardiomyopathy, or obstructive valve disease
* Renal transplant within the previous 6 months
* Severe nephritic syndrome not in remission

Primary outcomes:
measure: Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)
timeFrame: Day 0 to 3 weeks
measure: Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)
timeFrame: Day 0 (baseline) to 3 weeks
Secondary outcomes:
measure: Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
timeFrame: Week 3 (period 3 baseline) to week 5 (end of Period 3)
measure: Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
timeFrame: Week 3 (period 3 baseline) to week 5 (end of Period 3)
measure: Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
timeFrame: Day 0 to week 51 (end of study)
measure: Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
timeFrame: Day 0 to week 51 week (end of study)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Beverly Hills
country: United States
state: California
city: Fresno
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Park Ridge
country: United States
state: Illinois
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Grand Rapids
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: Hackensack
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Kinston
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Beaumont
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: San Miguel de Tucuman
country: Argentina
state: TUC
city: Bahia Blanca
country: Argentina
city: Buenos Aires
country: Argentina
city: Capital Federal
country: Argentina
city: Mar del Plata
country: Argentina
city: Campinas
country: Brazil
city: Curitiba
country: Brazil
city: Porto Alegre
country: Brazil
city: Recife
country: Brazil
city: Sao Paulo
country: Brazil
city: Santiago
country: Chile
city: Bogota
country: Colombia
city: Cali-Valle
country: Colombia
city: Ahmedabad
country: India
state: Gujarat
city: Mangalore
country: India
state: Karna
city: Vellore
country: India
state: Karna
city: Trivandrum
country: India
state: Kerala
city: Lucknow
country: India
state: Uttar Prad
city: Chandigarh
country: India
city: Hyderabad
country: India
city: New Delhi
country: India
city: Tamil Nadu
country: India
city: Nairobi
country: Kenya
city: Lima
country: Peru
city: Bloemfontein
country: South Africa
city: Cape Town
country: South Africa
city: Durban, KZ-Natal
country: South Africa
city: E Cape
country: South Africa
city: Eastern Cape
country: South Africa
city: Park Town, Gauteng
country: South Africa
city: Pietermaritzburg, KZ-Natal
country: South Africa
city: Potchefstroom, NW
country: South Africa
city: Pretoria, Gauteng
country: South Africa
city: Western Cape
country: South Africa
city: Kampala
country: Uganda
city: Kitwe
country: Zambia
city: Lusaka
country: Zambia
Study officials:
References: