A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension (0954A-327)

Study Overview
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Brief Summary
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The purpose of this study is to test the safety and effectiveness of Losartan as compared to Losartan/HCTZ in pediatric patients (6 to 17 years) with high blood pressure.

Detailed Description
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Participants who meet eligibility requirements will enter the single-blind Filter Period. Participants with either sitting systolic blood pressure (SiSBP) or sitting diastolic blood pressure (SiDBP) >=95th percentile for gender/age/height will be administered either losartan 25 mg or losartan 50 mg depending on body weight (<50 kg and >=50 kg, respectively). After 3 weeks, if SiSBP or SiDBP is >=95th percentile, participants will titrate to either losartan 50 mg or 100 mg according to weight. Participants with both SiSBP and SiDBP <95th percentile will be excluded from the study. After an additional 3 weeks, participants whose blood pressure (either SiSBP or SiDBP) remains >=95th percentile will then enter the double-blind phase. Participants who meet all entry criteria will be randomized in a 1:1 fashion to either losartan or losartan/hydrochlorothiazide (HCTZ) for 4 weeks and will be stratified according to body weight (<50 kg and >=50 kg). Participants whose weight is <50 kg will be randomized to losartan 50 mg or losartan50 mg/HCTZ 12.5 mg. Participants weighing >=50 kg will be randomized to losartan 100 mg or losartan/HCTZ 100 mg/12.5 mg. At the end of double-blind treatment, participants may enter a 20-week double-blind extension and will continue on their randomized therapy with losartan or losartan/HCTZ. 40 participants were enrolled and screened; the trial was terminated before any participants were randomized into the double-blind treatment period.

Official Title
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A Randomized, Double-Blind, Active Comparator Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan/HCTZ Combination as Compared to Losartan Monotherapy in Pediatric Patients With Essential Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: hydrochlorothiazide (+) losartan potassium
* Drug: losartan potassium
* Drug: Placebo for Losartan
* Drug: Placebo for Losartan/HCTZ


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is male/female and 6 to 17 years of age at the time of study with hypertension (high blood pressure) Patient is able to swallow tablets Females of child bearing potential must use acceptable contraception throughout the trial Exclusion Criteria: Patient has a history of heart, metabolic or kidney disease Patient has a history of known heart, lung, liver and other body system disorders Patient is pregnant or nursing Patient has participated in another clinical trial within the last 28 days

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Losartan 50 mg<br>Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks | Drug: losartan potassium<br>* Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period<br>* Other names: MK0954;Drug: Placebo for Losartan/HCTZ<br>* losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.<br>|
| Active Comparator: Losartan 100 mg<br>Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks | Drug: losartan potassium<br>* Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period<br>* Other names: MK0954;Drug: Placebo for Losartan/HCTZ<br>* losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.<br>|
| Experimental: Losartan 50 mg/HCTZ 12.5 mg<br>Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks | Drug: hydrochlorothiazide (+) losartan potassium<br>* losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.<br>* Other names: MK0954A;Drug: Placebo for Losartan<br> <br> |
| Experimental: Losartan 100 mg/HCTZ 12.5 mg<br>Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks | Drug: hydrochlorothiazide (+) losartan potassium<br>* losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.<br>* Other names: MK0954A;Drug: Placebo for Losartan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period |  | Baseline and Week 4 | 
| Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study |  | up to 4 weeks | 
| Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event During Double-blind Treatment Phase of Study |  | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period |  | Baseline and Week 4 |