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.
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.
Minimum age: 1 Year.
Maximum age: 16 Years.
Gender(s): Both.
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
Bahia Blanca, Argentina
Buenos Aires, Argentina
Capital Federal, Argentina
Mar del Plata, Argentina
Campinas, Brazil
Curitiba, Brazil
Porto Alegre, Brazil
Recife, Brazil
Sao Paulo, Brazil
Santiago, Chile
Bogota, Colombia
Cali-Valle, Colombia
Chandigarh, India
Hyderabad 500 033, India
New Delhi 110 029, India
Tamil Nadu, India
Nairobi, Kenya
Lima, Peru
Bloemfontein 9300, South Africa
Cape Town 7764, South Africa
Durban, KZ-Natal, South Africa
E Cape, South Africa
Eastern Cape 5200, South Africa
Park Town, Gauteng, South Africa
Pietermaritzburg, KZ-Natal, South Africa
Potchefstroom, NW, South Africa
Pretoria, Gauteng, South Africa
Western Cape 7130, South Africa
Kampala, Uganda
Kitwe, Zambia
Lusaka, Zambia
Birmingham, Alabama, United States
Phoenix, Arizona 85013, United States
Little Rock, Arkansas, United States
Beverly Hills, California, United States
Fresno, California, United States
Los Angeles, California 90049, United States
Washington, District of Columbia, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida 33647, United States
Decatur, Georgia, United States
Ahmedabad, Gujarat, India
Honolulu, Hawaii, United States
Park Ridge, Illinois, United States
Mangalore, Karna, India
Vellore, Karna, India
Trivandrum, Kerala, India
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Grand Rapids, Michigan, United States
Las Vegas, Nevada, United States
Hackensack, New Jersey, United States
New Brunswick, New Jersey, United States
Kinston, North Carolina, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Portland, Oregon, United States
San Miguel de Tucuman, TUC, Argentina
Beaumont, Texas, United States
Houston, Texas, United States
Lucknow, Uttar Prad, India
Charlottesville, Virginia, United States