Phase 3 Completed N=362 Randomized Double-blind Treatment

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

Hypertension

Source: ClinicalTrials.gov NCT00151775 ↗

Enrolled (actual)

362

Serious AEs

3.5%

Results posted

Apr 2010

Primary outcomePrimary: Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks) — -0.69; -0.85; -0.75; -8.97 mm Hg — p=0.0008

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)	-0.69; -0.85; -0.75; -8.97; -7.17; -8.36	0.0008 sig
PRIMARY Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)	-7.76; -12.58; -4.73; -10.68; -6.63; -11.87	0.0008 sig
SECONDARY Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3	1.36; 4.95; 0.31; 3.77	0.2113
SECONDARY Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)	-15.7; -13.3	—

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

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Data sourced from ClinicalTrials.gov (NCT00151775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.