Hypertension
Conditions
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.
Interventions
DRUGhydrochlorothiazide (+) losartan potassium
losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.
DRUGlosartan potassium
Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period
DRUGPlacebo for Losartan/HCTZ
losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period | Baseline and Week 4 |
Participant flow
Recruitment details
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.
Pre-assignment details
Enrolled participants entered screening. If initial criteria were met, eligible participants were separated into 2 strata based on weight and administered either 25-50mg or 50-100mg Losartan during Filter Period. Participant's whose blood pressure did not respond were eligible to be randomly assigned to the Treatment period of the study.
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Participants who met initial screening criteria for inclusion in study and were enrolled in the study. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Filter Period | Adverse Event | 0 | 0 | 1 |
| Filter Period | Screen Failure | 0 | 3 | 4 |
| Filter Period | Study terminated by Sponsor | 0 | 1 | 10 |
| Screening | Protocol Violation | 1 | 0 | 0 |
| Screening | Screen Failure | 4 | 0 | 0 |
| Screening | Study Terminated by Sponsor | 15 | 0 | 0 |
| Screening | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | All Enrolled |
|---|---|
| Age, Continuous | 13.7 years STANDARD_DEVIATION 2.58 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 4 | 2 / 15 |
| serious Total, serious adverse events | 0 / 4 | 0 / 15 |
Outcome results
Primary
Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period
Time frame: Baseline and Week 4
Population: Full Analysis Set (FAS) Population, defined as all participants who were randomly assigned to a treatment arm for double-blind treatment period of study. This analysis was not done. The study was terminated before any participants were randomized to a treatment arm.
Primary
Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study
Time frame: up to 4 weeks
Population: All Participants as Treated (APaT) Population, defined as participants who were randomly assigned to a treatment arm and who received at least 1 dose of study therapy. Study terminated early; no participant entered treatment period of study.
Primary
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
Population: All Participants as Treated (APaT) Population, defined as participants who were randomly assigned to a treatment arm and who received at least 1 dose of study therapy. Study terminated early; no participant entered treatment period of study.
Secondary
Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period
Time frame: Baseline and Week 4
Population: Full Analysis Set (FAS) Population, defined as all participants who were randomly assigned to a treatment arm for double-blind treatment period of study. This analysis was not done. The study was terminated before any participants were randomized to a treatment arm.