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

Organon

Status and phase: Terminated; Phase 3

Conditions: Hypertension

Treatments: Drug: Placebo for Losartan/HCTZ; Drug: losartan potassium; Drug: hydrochlorothiazide (+) losartan potassium; Drug: Placebo for Losartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00447603

2007_502

0954A-327

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups

Losartan 50 mg

Active Comparator group

Description:

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

Treatment:

Drug: losartan potassium

Drug: Placebo for Losartan/HCTZ

Losartan 100 mg

Active Comparator group

Description:

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

Treatment:

Drug: losartan potassium

Drug: Placebo for Losartan/HCTZ

Losartan 50 mg/HCTZ 12.5 mg

Experimental group

Description:

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

Treatment:

Drug: Placebo for Losartan

Drug: hydrochlorothiazide (+) losartan potassium

Losartan 100 mg/HCTZ 12.5 mg

Experimental group

Description:

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

Treatment:

Drug: Placebo for Losartan

Drug: hydrochlorothiazide (+) losartan potassium