Clinical Trials Directory

Trials / Completed

CompletedNCT00756938

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

A Phase III, Randomized, Open-Label, Parallel-Group, Dose-Ranging Clinical Trial to Study the Safety and Efficacy of MK954/Losartan Potassium in Pediatric Patients With Hypertension

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
101 (actual)
Sponsor
Organon and Co · Industry
Sex
All
Age
6 Months – 6 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGlosartan potassiumlosartan potassium, dry powder, to be suspended in liquid and given orally, once daily; doses will start at 0.1 mg/kg, 0.3 mg/kg, and 0.7 mg/kg, respectively, in the three study arms and can be escalated up to 1.4 mg/kg (maximum dose 100 mg) until target blood pressure is reached.

Timeline

Start date
2009-03-01
Primary completion
2012-08-14
Completion
2012-08-14
First posted
2008-09-22
Last updated
2024-06-18
Results posted
2014-03-03

Source: ClinicalTrials.gov record NCT00756938. Inclusion in this directory is not an endorsement.