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

• Sponsor: Organon and Co (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00447603
• Collaborator: (none)
• Enrollment: 40
• Arms: 4
• Actual Duration (Months): 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: hydrochlorothiazide (+) losartan potassium; Drug: losartan potassium; Drug: Placebo for Losartan; Drug: Placebo for Losartan/HCTZ	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 24, 2007
• Actual Primary Completion Date: Oct 22, 2007
• Actual Study Completion Date: Oct 22, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Losartan 50 mg 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; Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period; Other Names: MK0954 ; Drug: Placebo for Losartan/HCTZ; losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
Active Comparator: Losartan 100 mg 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; Losartan 50mg titrating up to Losartan 100mg tablet po qd; for a 4 week study period; Other Names: MK0954 ; Drug: Placebo for Losartan/HCTZ; losartan/hydrochlorothiazide 12.5mg Pbo tablet po qd; for a 4 week study period.
Experimental: Losartan 50 mg/HCTZ 12.5 mg 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; losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.; Other Names: MK0954A ; Drug: Placebo for Losartan
Experimental: Losartan 100 mg/HCTZ 12.5 mg 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; losartan/hydrochlorothiazide 12.5mg tablet po qd; for a 4 week study period.; Other Names: MK0954A ; Drug: Placebo for Losartan

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period [Baseline and Week 4]

2. Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study [up to 4 weeks]

3. 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 Outcome Measures

1. Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period [Baseline and Week 4]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00447603
• Other Study ID Numbers: 0954A-327; 2007_502
• First Posted: Mar 15, 2007
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Hypertension; Losartan; Hydrochlorothiazide

Study Results

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 Detail	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.

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

Baseline Characteristics

Arm/Group Title	All Enrolled
Arm/Group Description	Participants who met initial screening criteria for inclusion in study and were enrolled in the study.
Overall Participants	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	13.7 (2.58)
Sex: Female, Male (Count of Participants)
Female	9 22.5%
Male	31 77.5%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Sitting Trough Systolic Blood Pressure (SiSBP) at Week 4 of Double-blind Treatment Period
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Losartan 50 mg	Losartan 100 mg	Losartan 50 mg/HCTZ 12.5 mg	Losartan 100 mg/HCTZ 12.5 mg
Arm/Group Description	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	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	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	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
Measure Participants	0	0	0	0

2. Primary Outcome

Title	Number of Participants Who Experience an Adverse Event During Double-blind Treatment Phase of Study
Time Frame	up to 4 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Losartan 50 mg	Losartan 100 mg	Losartan 50 mg/HCTZ 12.5 mg	Losartan 100 mg/HCTZ 12.5 mg
Arm/Group Description	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	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	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	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
Measure Participants	0	0	0	0

3. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Losartan 50 mg	Losartan 100 mg	Losartan 50 mg/HCTZ 12.5 mg	Losartan 100 mg/HCTZ 12.5 mg
Arm/Group Description	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	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	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	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
Measure Participants	0	0	0	0

4. Secondary Outcome

Title	Change From Baseline in Sitting Trough Diastolic Blood Pressure (SiDBP) at Week 4 of Double-blind Treatment Period
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Losartan 50 mg	Losartan 100 mg	Losartan 50 mg/HCTZ 12.5 mg	Losartan 100 mg/HCTZ 12.5 mg
Arm/Group Description	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	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	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	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
Measure Participants	0	0	0	0

Adverse Events

Time Frame	up to 6 weeks (Filter period)
Adverse Event Reporting Description	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.
Arm/Group Title	Losartan 25 Mg-50 mg (Filter Period)		Losartan 50 Mg-100 mg (Filter Period)
Arm/Group Description	Participants <50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks		Participants >=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
All Cause Mortality
	Losartan 25 Mg-50 mg (Filter Period)		Losartan 50 Mg-100 mg (Filter Period)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Losartan 25 Mg-50 mg (Filter Period)		Losartan 50 Mg-100 mg (Filter Period)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Losartan 25 Mg-50 mg (Filter Period)		Losartan 50 Mg-100 mg (Filter Period)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/4 (25%)		2/15 (13.3%)
Infections and infestations
Pharyngitis	0/4 (0%)	0	1/15 (6.7%)	1
Injury, poisoning and procedural complications
Mouth injury	1/4 (25%)	1	0/15 (0%)	0
Vascular disorders
Hypotension	0/4 (0%)	0	1/15 (6.7%)	1

Limitations/Caveats

The study was discontinued early (during screening) due to limited availability of sites and readiness of sites to enroll participants within the predefined time.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.