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OpenTrials
Completed

NCT Number: NCT00756938

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Losartan Potassium

Drug

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 names: Cozaar

Primary outcomes

  1. 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.

  2. 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)

  3. 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)

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 22, 2008
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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