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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Olmesartan; Olmesartan Medoxomil

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