HypertensionPhase 3NCT00756938

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

A Phase 3 study testing losartan potassium in people with Hypertension, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 6 months to 6 years
Conditions the study is for: Hypertension
What is being tested?: losartan potassium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: No sites listed yet
Study dates: 1 Mar 2009to 14 Aug 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

Participant is determined to be hypertensive

Who cannot join

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

About this study

Official 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

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
Being tested: losartan potassium
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

losartan potassiumDrug
Also called Cozaar
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.

Study groups in NCT00756938
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: Drug: losartan potassium

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Day 21
Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)
Measured: 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
Measured: up to 12 weeks (Base Study); up to 24 months (Extension)

Secondary outcomes (1)

Mean Change From Baseline in Diastolic Blood Pressure
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.
Measured: Baseline and Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 200914 Aug 2012

First posted22 Sep 2008 (estimated)
Study start1 Mar 2009
Primary completion14 Aug 2012
Study completion14 Aug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00756938
Sponsor's protocol ID: 0954-337
Other IDs: 2008_545, CTRI/2009/091/000045
Status last verified: Feb 2022
First submitted: 18 Sep 2008
Last updated: 18 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 24875194

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT00756938
Acronym / sponsor ID: 0954-337
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 1 Mar 2009 (actual)
Primary completion: 14 Aug 2012 (actual)
Study completion: 14 Aug 2012 (actual)
First posted: 22 Sep 2008 (estimated)
Results: Posted 3 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Losartan potassium 0.1 to 1.4 mg/kg	Experimental	Drug: losartan potassiumOpen-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
Losartan potassium 0.3 to 1.4 mg/kg	Experimental	Drug: losartan potassiumOpen-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
Losartan potassium 0.7 to 1.4 mg/kg	Experimental	Drug: losartan potassiumOpen-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

Who may qualify

Ages: 6 months to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Participant is determined to be hypertensive

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
losartan potassiumAlso: Cozaarlosartan 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.	Drug	Losartan potassium 0.1 to 1.4 mg/kg, Losartan potassium 0.3 to 1.4 mg/kg, Losartan potassium 0.7 to 1.4 mg/kg

Primary outcome

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)

1 secondary outcome

Mean Change From Baseline in Diastolic Blood Pressure
Time frame: Baseline and Day 21

Results and safety

Results posted to the registry on 3 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Losartan Potassium 0.1 to 1.4 mg/kg	33	31
Losartan Potassium 0.3 to 1.4 mg/kg	34	34
Losartan Potassium 0.7 to 1.4 mg/kg	34	32
Losartan Potassium-Extension	0	0

Primary outcome: Mean Change From Baseline in Systolic Blood Pressure

Time frame: Baseline and Day 21. Mean (Standard Deviation). Unit: mmHg

Measure	Losartan Potassium 0.1 to 1.4 mg/kg n = 32	Losartan Potassium 0.3 to 1.4 mg/kg n = 34	Losartan Potassium 0.7 to 1.4 mg/kg n = 33
Value	-7.31 (12.53)	-7.65 (7.49)	-6.67 (7.86)

Losartan Potassium 0.1 to 1.4 mg/kg vs Losartan Potassium 0.3 to 1.4 mg/kg vs Losartan Potassium 0.7 to 1.4 mg/kg: Slope: 1.22 (95% CI -6.45 to 8.90), p = 0.753, ANCOVA

Population analysed: Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation

Primary outcome: 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. Unit: Participants

Measure	Base Study-Losartan Potassium 0.1 mg/kg n = 34	Base Study-Losartan Potassium 0.3 mg/kg n = 54	Base Study-Losartan Potassium 0.7 mg/kg n = 63	Base Study-Losartan Potassium 1.4 mg/kg n = 33	Extension-Losartan Potassium n = 90
Clinical Adverse Event	21	30	36	22	75
Laboratory Adverse Event	1	1	0	0	5

Population analysed: All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.

Primary outcome: 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). Number. Unit: Participants

Measure	Base Study-Losartan Potassium 0.1 mg/kg n = 34	Base Study-Losartan Potassium 0.3 mg/kg n = 54	Base Study-Losartan Potassium 0.7 mg/kg n = 63	Base Study-Losartan Potassium 1.4 mg/kg n = 33	Extension-Losartan Potassium n = 90
Clinical Adverse Event	0	0	0	0	1
Laboratory Adverse Event	0	0	0	0	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: up to 12 weeks (Base Study); up to 24 months (Extension). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Base Study-Losartan Potassium 0.1 mg/kg/Day	3 of 34 (8.8%)	15 of 34 (44.1%)	Not reported
Base Study-Losartan Potassium 0.3 mg/kg/Day	2 of 54 (3.7%)	22 of 54 (40.7%)	Not reported
Base Study-Losartan Potassium 0.7 mg/kg/Day	2 of 63 (3.2%)	23 of 63 (36.5%)	Not reported
Base Study-Losartan 1.4 mg/kg/Day	0 of 33 (0%)	17 of 33 (51.5%)	Not reported
Extension-Losartan 0.1 mg/kg/Day	3 of 15 (20%)	12 of 15 (80%)	Not reported
Extension-Losartan 0.3 mg/kg/Day	5 of 28 (17.9%)	20 of 28 (71.4%)	Not reported
Extension-Losartan 0.7 mg/kg/Day	2 of 31 (6.5%)	20 of 31 (64.5%)	Not reported
Extension-Losartan 1.4 mg/kg/Day	5 of 42 (11.9%)	28 of 42 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24875194Webb 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.
Individual participant dataSharing planned: No

Related trials for Hypertension

Active, not recruiting
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Chronic Kidney Disease, Hypertension (HTN)
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Trial Phase: Syndemic Adapted Medly Uganda
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing losartan potassium in people with Hypertension, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Systolic Blood Pressure (time frame: Baseline and Day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00756938, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.