Phase 3 Completed N=101 Randomized Treatment

Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)

Hypertension

Source: ClinicalTrials.gov NCT00756938 ↗

Enrolled (actual)

101

Serious AEs

7.3%

Results posted

Mar 2014

Primary outcomePrimary: Mean Change From Baseline in Systolic Blood Pressure — -7.31; -7.65; -6.67 mmHg — p=0.753

Summary

This study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Systolic Blood Pressure	-7.31; -7.65; -6.67	0.753
PRIMARY Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)	21; 30; 36; 22; 75; 1	—
PRIMARY Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event	0; 0; 0; 0; 1; 0	—
SECONDARY Mean Change From Baseline in Diastolic Blood Pressure	-8.25; -5.15; -6.73	0.643

Eligibility Criteria

Inclusion Criteria

Participant is determined to be hypertensive

Exclusion Criteria

Participant has a history of severe or symptomatic hypertension
Participant has history of heart failure, rhythm disturbance or cardiomyopathy, or obstructive valvular disease
Participant has started taking hypertensive medications within the past 30 days
Participant has a known sensitivity to losartan or history of angioneurotic edema

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00756938). 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.