Study of Losartan in Pediatric Patients With Hypertension


Tracking Information

Start Date  ICMJEMarch 2009
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: October 26, 2009)		To define a dose-response relationship for losartan in hypertensive children ages 6 months to 6 years specifically the change from baseline in systolic blood pressure. [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJE 
 (submitted: September 19, 2008)		To investigate the safety and tolerability of losartan in hypersensitive children ages 6 months to 6 years [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: Yes ]
Change HistoryComplete list of historical versions of study NCT00756938 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: October 26, 2009)		To investigate the safety and tolerability of losartan in hypertensive children ages 6 months to 6 years. Safety will be primarily measured by the number of patients with adverse experiences during the 12-week base study and extension. [ Time Frame: After 21 day treatment period ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: September 19, 2008)		To define a dose-response relationship for losartan in hypersensitive children ages 6 months to 6 years [ Time Frame: After 21 day treatment period ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title  ICMJEStudy of Losartan in Pediatric Patients With Hypertension
Official Title  ICMJEA 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
Brief Summary

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

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEHypertension
Intervention  ICMJE
  • Drug: Losartan 0.1 mg/kg/day titrating to a maximum dose of 1.4 mg/kg/day (not to exceed 100 mg/day) if blood pressure not at goal
    Arm 1: starting dose is 0.1 mg/kg/day. Titrate dose at Week 3 to 0.3 mg/kg/day. At Week 6 titrate dose to 0.7 mg/kg/day. At week 9 titrate dose to 1.4 mg/kg/day. Treatment period is 12 weeks.
    Other Name: Cozaar
  • Drug: Losartan 0.3 mg/kg/day titrating to a maximum dose of 1.4 mg/kg/day (not to exceed 100 mg/day) if blood pressure not at goal
    Arm 2: starting dose of losartan is 0.3 mg/kg/day. At week 3 titrate dose to 0.7 mg/kg/day. At week 6 titrate dose to 1.4 mg/kg/day and will continue with dose until end of treatment. Treatment period is 12 weeks.
    Other Name: Cozaar
  • Drug: Losartan 0.7 mg/kg/day titrating to a maximum dose of 1.4 mg/kg/day (not to exceed 100 mg/day) if blood pressure not at goal
    Arm 3: Starting dose of Losartan is 0.7 mg/kg/day. At week 3 titrate dose to 1.4 mg/kg/day and continue on dose until end of treatment. Treatment period is 12 weeks.
    Other Name: Cozaar
Study Arms / Comparison Groups
  • 1: Experimental
    Losartan
    Intervention: Drug: Losartan 0.1 mg/kg/day titrating to a maximum dose of 1.4 mg/kg/day (not to exceed 100 mg/day) if blood pressure not at goal
  • 2: Experimental
    Losartan
    Intervention: Drug: Losartan 0.3 mg/kg/day titrating to a maximum dose of 1.4 mg/kg/day (not to exceed 100 mg/day) if blood pressure not at goal
  • 3: Experimental
    Losartan
    Intervention: Drug: Losartan 0.7 mg/kg/day titrating to a maximum dose of 1.4 mg/kg/day (not to exceed 100 mg/day) if blood pressure not at goal

Recruitment Information

Estimated Enrollment  ICMJE100
Estimated Completion DateDecember 2010
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is male or female 6 months to 6 years of age
  • Patient is determined to be hypertensive

Exclusion Criteria:

  • Patient has a history of severe or symptomatic hypertension
  • Patient has history of heart failure, rhythm disturbance or cardiomyopathy, or obstructive valvular disease
  • Patient has started taking hypertensive medications within the past 30 days
  • Patient has a known sensitivity to losartan or history of angioneurotic edema
GenderBoth
Ages6 Months to 6 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Toll Free Number1-888-577-8839
Location Countries  ICMJEUnited States,   Argentina,   Brazil,   Chile,   Colombia,   Guatemala,   Hungary,   India,   Lithuania,   Norway,   Philippines,   Romania,   Russian Federation,   Spain,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00756938
Responsible PartyExecutive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Study ID Numbers  ICMJE2008_545, MK0954-337
Study Sponsor  ICMJEMerck
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorMerck
Information Provided ByMerck