Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00151775

Run by

Daiichi Sankyo

People needed

362

Starts

2005-05-01

Expected to finish

2008-09-01

Last updated by the study team

2016-06-30

Who can join

Age: 1 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Beverly Hills, California, United States
• Study site — Fresno, California, United States
• Study site — Los Angeles, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Park Ridge, Illinois, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Hackensack, New Jersey, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Kinston, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Dayton, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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