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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00447603
• Other study ID #: 0954A-327
• Secondary ID: 2007_502
• Status: Terminated
• Phase: Phase 3
• Start date: May 24, 2007
• Est. completion date: October 22, 2007

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: October 22, 2007
• Est. primary completion date: October 22, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• hydrochlorothiazide (+) losartan potassium
losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.
• losartan potassium
Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period
• Placebo for Losartan

• Placebo for Losartan/HCTZ
losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period		Baseline and Week 4
Primary	Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study		up to 4 weeks
Primary	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	Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period		Baseline and Week 4