Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-29 @ 9:11 AM
Study NCT ID:
NCT00447603
Status:
TERMINATED
Last Update Posted:
2024-06-18
First Post:
2007-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension (0954A-327)
Sponsor:
Organon and Co
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Achieving site readiness and enrolling the trial within a reasonable time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
40 participants were enrolled and screened; the trial was terminated before any participants were randomized into the double-blind treatment period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007_502 | None | None | View |