Trial Outcomes & Findings for A Study of Losartan Compared to Losartan/HCTZ in Pediatric Patients With Hypertension (0954A-327) (NCT NCT00447603)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

Baseline and Week 4

Results posted on

2024-06-18

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	All Enrolled Participants who met initial screening criteria for inclusion in study and were enrolled in the study.	Losartan 25 Mg-50 mg (Filter Period) Participants \<50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks	Losartan 50 Mg-100 mg (Filter Period) Participants \>=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
Screening STARTED	40	0	0
Screening COMPLETED	19	0	0
Screening NOT COMPLETED	21	0	0
Filter Period STARTED	0	4	15
Filter Period COMPLETED	0	0	0
Filter Period NOT COMPLETED	0	4	15

Reasons for withdrawal

Reasons for withdrawal
Measure	All Enrolled Participants who met initial screening criteria for inclusion in study and were enrolled in the study.	Losartan 25 Mg-50 mg (Filter Period) Participants \<50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks	Losartan 50 Mg-100 mg (Filter Period) Participants \>=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
Screening Withdrawal by Subject	1	0	0
Screening Protocol Violation	1	0	0
Screening Screen Failure	4	0	0
Screening Study Terminated by Sponsor	15	0	0
Filter Period Adverse Event	0	0	1
Filter Period Screen Failure	0	3	4
Filter Period Study terminated by Sponsor	0	1	10

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled n=40 Participants Participants who met initial screening criteria for inclusion in study and were enrolled in the study.
Age, Continuous	13.7 years STANDARD_DEVIATION 2.58 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Losartan 25 Mg-50 mg (Filter Period)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Losartan 50 Mg-100 mg (Filter Period)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Losartan 25 Mg-50 mg (Filter Period) n=4 participants at risk Participants \<50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks	Losartan 50 Mg-100 mg (Filter Period) n=15 participants at risk Participants \>=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
Infections and infestations Pharyngitis	0.00% 0/4 • up to 6 weeks (Filter period) Adverse events are reported for the 19 participants who were enrolled and entered the Filter Period. No participants entered the planned double-blind treatment period of this study.	6.7% 1/15 • Number of events 1 • up to 6 weeks (Filter period) Adverse events are reported for the 19 participants who were enrolled and entered the Filter Period. No participants entered the planned double-blind treatment period of this study.
Injury, poisoning and procedural complications Mouth injury	25.0% 1/4 • Number of events 1 • up to 6 weeks (Filter period) Adverse events are reported for the 19 participants who were enrolled and entered the Filter Period. No participants entered the planned double-blind treatment period of this study.	0.00% 0/15 • up to 6 weeks (Filter period) Adverse events are reported for the 19 participants who were enrolled and entered the Filter Period. No participants entered the planned double-blind treatment period of this study.
Vascular disorders Hypotension	0.00% 0/4 • up to 6 weeks (Filter period) Adverse events are reported for the 19 participants who were enrolled and entered the Filter Period. No participants entered the planned double-blind treatment period of this study.	6.7% 1/15 • Number of events 1 • up to 6 weeks (Filter period) Adverse events are reported for the 19 participants who were enrolled and entered the Filter Period. No participants entered the planned double-blind treatment period of this study.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
Publication restrictions are in place

Restriction type: OTHER