A Phase 3 interventional study of hydrochlorothiazide (+) losartan potassium and losartan potassium in Hypertension, sponsored by Organon and Co. Terminated. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-06-18.
Sponsored by Organon and Co · Phase 3, Interventional, and Treatment
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 40 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Placebo for Losartan/HCTZ
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 · Drug: Placebo for Losartan/HCTZ
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 · Drug: Placebo for Losartan
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 · Drug: Placebo for Losartan
losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.
Also known as: MK0954A
Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period
Also known as: MK0954
losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period
Time frame: Baseline and Week 4
Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study
Time frame: up to 4 weeks
Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event During Double-blind Treatment Phase of Study
Time frame: up to 4 weeks
Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period
Time frame: Baseline and Week 4
The study was discontinued early due to limited availability of sites and readiness of sites to enroll participants within the predefined time. Although some participants were screened and entered Filter Period, none were randomly assigned to a treatment arm and none entered double-blind treatment period.
| Milestone | All Enrolled | Losartan 25 Mg-50 mg (Filter Period) | Losartan 50 Mg-100 mg (Filter Period) |
|---|---|---|---|
| Started | 40 | 0 | 0 |
| Completed | 19 | 0 | 0 |
| Not completed | 21 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 |
| Withdrew: Screen failure | 4 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 15 | 0 | 0 |
| Milestone | All Enrolled | Losartan 25 Mg-50 mg (Filter Period) | Losartan 50 Mg-100 mg (Filter Period) |
|---|---|---|---|
| Started | 0 | 4 | 15 |
| Completed | 0 | 0 | 0 |
| Not completed | 0 | 4 | 15 |
| Withdrew: Adverse event | 0 | 0 | 1 |
| Withdrew: Screen failure | 0 | 3 | 4 |
| Withdrew: Study terminated by sponsor | 0 | 1 | 10 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over up to 6 weeks (Filter period). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Losartan 25 Mg-50 mg (Filter Period) | — | 0/4 (0%) | 1/4 (25%) |
| Losartan 50 Mg-100 mg (Filter Period) | — | 0/15 (0%) | 2/15 (13.3%) |
| Event | Losartan 25 Mg-50 mg (Filter Period) | Losartan 50 Mg-100 mg (Filter Period) |
|---|---|---|
| Mouth injuryInjury, poisoning and procedural complications | 1/4 | 0/15 |
| PharyngitisInfections and infestations | 0/4 | 1/15 |
| HypotensionVascular disorders | 0/4 | 1/15 |
All enrolled population which included all participants who provided consent and entered screening period of study.
| Age, Continuous(years) | All Enrolled |
|---|---|
| Mean | 13.7 ± 2.58 |
| Sex: Female, Male(Participants) | All Enrolled |
|---|---|
| Female | 9 |
| Male | 31 |
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Organon and Co