NCT00756938

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_3 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 3, 2014

Completed
Last Updated

June 18, 2024

Status Verified

February 1, 2022

Enrollment Period

3.5 years

First QC Date

September 18, 2008

Results QC Date

January 16, 2014

Last Update Submit

June 5, 2024

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

  • Mean Change From Baseline in Systolic Blood Pressure

    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.

    Baseline and Day 21

  • Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)

    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

    up to 12 weeks (Base Study); up to 24 months (Extension)

Secondary Outcomes (1)

  • Mean Change From Baseline in Diastolic Blood Pressure

    Baseline and Day 21

Study Arms (3)

Losartan potassium 0.1 to 1.4 mg/kg

EXPERIMENTAL

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

Drug: losartan potassium

Losartan potassium 0.3 to 1.4 mg/kg

EXPERIMENTAL

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

Drug: losartan potassium

Losartan potassium 0.7 to 1.4 mg/kg

EXPERIMENTAL

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

Drug: losartan potassium

Interventions

losartan potassiumDRUG

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.

Also known as: Cozaar
Losartan potassium 0.1 to 1.4 mg/kgLosartan potassium 0.3 to 1.4 mg/kgLosartan potassium 0.7 to 1.4 mg/kg

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Participant is determined to be hypertensive

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 24875194RESULT

MeSH Terms

Conditions

Hypertension

Interventions

Losartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2008

First Posted

September 22, 2008

Study Start

March 1, 2009

Primary Completion

August 14, 2012

Study Completion

August 14, 2012

Last Updated

June 18, 2024

Results First Posted

March 3, 2014

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share