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

NCT ID: NCT00756938

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-01
• Study Completion Date: 2012-08-14

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

losartan potassium

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

losartan potassium

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

losartan potassium

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Cozaar

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 24875194 (View on PubMed)

Other Identifiers

2008_545

Identifier Type: OTHER

Identifier Source: secondary_id

CTRI/2009/091/000045

Identifier Type: REGISTRY

Identifier Source: secondary_id

0954-337

Identifier Type: -

Identifier Source: org_study_id