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 patients can continue to take olmesartan medoxomil for up to one year in the study.

Condition	Intervention	Phase
Hypertension	Drug: Olmesartan medoxomil	Phase II Phase III

Further Study Details: 

Primary Outcomes: For children ages 6-16: Change from study baseline in trough SeSBP or in trough SeDBP; For children 1-6: Change from Period III baseline in trough seated SeSBP or SeDBP to the end of Period III
Secondary Outcomes: For children ages 6-16: Difference in SeSBP or in SeDBP between the trough values at the end of Period II and at the end of Period III for the omlesartan-treated patients vs the placebo-treated patients; For all participants: AEs, clinical laboratory assessments, vital signs, physical examination, investigator based neurocognitive assessment via evaluation of developmental milestones at the beginning and at the conclusion of the study
Expected Total Enrollment:  240

Ages Eligible for Study:  1 Year   -   16 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• The patient''''s seated systolic and/or diastolic BP (SeSBP and/or SeDBP) 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

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00151775

Darren Cross      1-919-998-7695    darren.cross@quintiles.com
Eeva-Kaarina Koskelo      +27-12-671-2303    eeva-kaarina.koskelo@quintiles.com

Alabama
      Birmingham,  Alabama,  United States; Recruiting
Arkansas
      Little Rock,  Arkansas,  United States; Recruiting
California
      Fresno,  California,  United States; Recruiting
      Beverly Hills,  California,  United States; Recruiting
District of Columbia
      Washington,  District of Columbia,  United States; Recruiting
Florida
      Orlando,  Florida,  United States; Recruiting
      Jacksonville,  Florida,  United States; Recruiting
      Miami,  Florida,  United States; Recruiting
Georgia
      Decatur,  Georgia,  United States; Recruiting
Hawaii
      Honolulu,  Hawaii,  United States; Recruiting
Illinois
      Park Ridge,  Illinois,  United States; Recruiting
Louisiana
      New Orleans,  Louisiana,  United States; Recruiting
      Shreveport,  Louisiana,  United States; Recruiting
Maryland
      Baltimore,  Maryland,  United States; Recruiting
Michigan
      Grand Rapids,  Michigan,  United States; Recruiting
Nevada
      Las Vegas,  Nevada,  United States; Recruiting
New Jersey
      Hackensack,  New Jersey,  United States; Recruiting
      New Brunswick,  New Jersey,  United States; Recruiting
Ohio
      Cincinnati,  Ohio,  United States; Recruiting
      Dayton,  Ohio,  United States; Recruiting
Oregon
      Portland,  Oregon,  United States; Recruiting
Texas
      Beaumont,  Texas,  United States; Recruiting
      Houston,  Texas,  United States; Recruiting
Virginia
      Charlottesville,  Virginia,  United States; Recruiting
Argentina
      Capital Federal,  Argentina; Recruiting
      Bahia Blanca,  Argentina; Recruiting
      Mar del Plata,  Argentina; Recruiting
Argentina, TUC
      San Miguel de Tucuman,  TUC,  Argentina; Recruiting
Brazil
      Sao Paulo,  Brazil; Recruiting
      Porto Alegre,  Brazil; Recruiting
      Curitiba,  Brazil; Recruiting
      Campinas,  Brazil; Recruiting
      Recife,  Brazil; Recruiting
Chile
      Santiago,  Chile; Recruiting
Colombia
      Bogota,  Colombia; Recruiting
      Cali-Valle,  Colombia; Recruiting
India
      Chandigarh,  India; Recruiting
India, Gujarat
      Ahmedabad,  Gujarat,  India; Recruiting
India, Karna
      Vellore,  Karna,  India; Recruiting
      Mangalore,  Karna,  India; Recruiting
India, Kerala
      Trivandrum,  Kerala,  India; Recruiting
India, Uttar Prad
      Lucknow,  Uttar Prad,  India; Recruiting
Kenya
      Nairobi,  Kenya; Recruiting
Peru
      Lima,  Peru; Recruiting
South Africa
      Durban, KZ-Natal,  South Africa; Recruiting
      Potchefstroom, NW,  South Africa; Recruiting
      Pietermaritzburg, KZ-Natal,  South Africa; Recruiting
      E Cape,  South Africa; Recruiting
      Pretoria, Gauteng,  South Africa; Recruiting
      Park Town, Gauteng,  South Africa; Recruiting
Uganda
      Kampala,  Uganda; Recruiting
Zambia
      Lusaka,  Zambia; Recruiting
      Kitwe,  Zambia; Recruiting

Study ID Numbers:  CS0866-A-U301
Last Updated:  September 8, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00151775
Health Authority: United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Health Suveillance Agency; Chile: Instituto de Salud Publica de Chile; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
ClinicalTrials.gov processed this record on 2005-09-13