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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00756938
First Posted: September 22, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
September 18, 2008
September 22, 2008
January 16, 2014
March 3, 2014
October 12, 2017
March 1, 2009
August 14, 2012   (Final data collection date for primary outcome measure)
  • Mean Change From Baseline in Systolic Blood Pressure [ Time Frame: Baseline and Day 21 ]
    Sitting blood pressure ([BP] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.
  • Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s) [ Time Frame: up to 12 weeks (Base Study); up to 24 months (Extension) ]
  • Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event [ Time Frame: up to 12 weeks (Base Study); up to 24 months (Extension) ]
To investigate the safety and tolerability of losartan in hypersensitive children ages 6 months to 6 years [ Time Frame: After 12 weeks of treatment ]
Complete list of historical versions of study NCT00756938 on ClinicalTrials.gov Archive Site
Mean Change From Baseline in Diastolic Blood Pressure [ Time Frame: Baseline and Day 21 ]
Sitting BP (or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Diastolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.
To define a dose-response relationship for losartan in hypersensitive children ages 6 months to 6 years [ Time Frame: After 21 day treatment period ]
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypertension
Drug: losartan potassium
losartan 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.
Other Name: Cozaar
  • Experimental: Losartan potassium 0.1 to 1.4 mg/kg
    Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
    Intervention: Drug: losartan potassium
  • Experimental: Losartan potassium 0.3 to 1.4 mg/kg
    Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
    Intervention: Drug: losartan potassium
  • Experimental: Losartan potassium 0.7 to 1.4 mg/kg
    Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
    Intervention: Drug: losartan potassium
Webb NJ, Wells TG, Shahinfar S, Massaad R, Dankner WM, Lam C, Santoro EP, McCrary Sisk C, Blaustein RO. A randomized, open-label, dose-response study of losartan in hypertensive children. Clin J Am Soc Nephrol. 2014 Aug 7;9(8):1441-8. doi: 10.2215/CJN.11111113. Epub 2014 May 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
August 14, 2012
August 14, 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Months to 6 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Argentina,   Brazil,   Chile,   Colombia,   Guatemala,   Hungary,   India,   Lithuania,   Norway,   Philippines,   Romania,   Russian Federation,   Spain,   United Kingdom,   United States
 
NCT00756938
0954-337
2008_545 ( Other Identifier: Merck Study Number )
CTRI/2009/091/000045 ( Registry Identifier: CTRI )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP