Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00756938
• Collaborator: (none)
• Enrollment: 101
• Arms: 3
• Actual Duration (Months): 41.5

Study Details

Study Description

Brief Summary

This study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: losartan potassium	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III, Randomized, Open-Label, Parallel-Group, Dose-Ranging Clinical Trial to Study the Safety and Efficacy of MK954/Losartan Potassium in Pediatric Patients With Hypertension
• Actual Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Aug 14, 2012
• Actual Study Completion Date: Aug 14, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Losartan potassium 0.1 to 1.4 mg/kg Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved	Drug: losartan potassium; losartan potassium, dry powder, to be suspended in liquid and given orally, once daily; doses will start at 0.1 mg/kg, 0.3 mg/kg, and 0.7 mg/kg, respectively, in the three study arms and can be escalated up to 1.4 mg/kg (maximum dose 100 mg) until target blood pressure is reached.; Other Names: Cozaar
Experimental: Losartan potassium 0.3 to 1.4 mg/kg Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved	Drug: losartan potassium; losartan potassium, dry powder, to be suspended in liquid and given orally, once daily; doses will start at 0.1 mg/kg, 0.3 mg/kg, and 0.7 mg/kg, respectively, in the three study arms and can be escalated up to 1.4 mg/kg (maximum dose 100 mg) until target blood pressure is reached.; Other Names: Cozaar
Experimental: Losartan potassium 0.7 to 1.4 mg/kg Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved	Drug: losartan potassium; losartan potassium, dry powder, to be suspended in liquid and given orally, once daily; doses will start at 0.1 mg/kg, 0.3 mg/kg, and 0.7 mg/kg, respectively, in the three study arms and can be escalated up to 1.4 mg/kg (maximum dose 100 mg) until target blood pressure is reached.; Other Names: Cozaar

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline in Systolic Blood Pressure [Baseline and Day 21]

   Sitting blood pressure ([BP] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.

2. Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s) [up to 12 weeks (Base Study); up to 24 months (Extension)]

3. Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event [up to 12 weeks (Base Study); up to 24 months (Extension)]

Secondary Outcome Measures

1. Mean Change From Baseline in Diastolic Blood Pressure [Baseline and Day 21]

   Sitting BP (or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Diastolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participant is determined to be hypertensive

Exclusion Criteria:

• Participant has a history of severe or symptomatic hypertension

• Participant has history of heart failure, rhythm disturbance or cardiomyopathy, or obstructive valvular disease

• Participant has started taking hypertensive medications within the past 30 days

• Participant has a known sensitivity to losartan or history of angioneurotic edema

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: NCT00756938
• Other Study ID Numbers: 0954-337; 2008_545; CTRI/2009/091/000045
• First Posted: Sep 22, 2008
• 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

Study Results

Participant Flow

Arm/Group Title	Losartan Potassium 0.1 to 1.4 mg/kg	Losartan Potassium 0.3 to 1.4 mg/kg	Losartan Potassium 0.7 to 1.4 mg/kg	Losartan Potassium-Extension
Arm/Group Description	Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved	Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved	Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved	Participants who elected to enter extension; dose level of Losartan was that which was being administered at end of base study
Period Title: 12-week Base Study
STARTED	33	34	34	0
COMPLETED	31	34	32	0
NOT COMPLETED	2	0	2	0
Period Title: 12-week Base Study
STARTED	0	0	0	90
COMPLETED	0	0	0	53
NOT COMPLETED	0	0	0	37

Baseline Characteristics

Arm/Group Title	Losartan Potassium 0.1 to 1.4 mg/kg	Losartan Potassium 0.3 to 1.4 mg/kg	Losartan Potassium 0.7 to 1.4 mg/kg	Total
Arm/Group Description	Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved	Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved	Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved	Total of all reporting groups
Overall Participants	33	34	34	101
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	40.2 (24.4)	45.0 (21.5)	40.6 (21.2)	42.0 (22.3)
Sex: Female, Male (Count of Participants)
Female	13 39.4%	16 47.1%	14 41.2%	43 42.6%
Male	20 60.6%	18 52.9%	20 58.8%	58 57.4%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline in Systolic Blood Pressure
Description	Sitting blood pressure ([BP] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.
Time Frame	Baseline and Day 21

Outcome Measure Data

Analysis Population Description

Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation

Arm/Group Title	Losartan Potassium 0.1 to 1.4 mg/kg	Losartan Potassium 0.3 to 1.4 mg/kg	Losartan Potassium 0.7 to 1.4 mg/kg
Arm/Group Description	Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved	Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved	Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
Measure Participants	32	34	33
Mean (Standard Deviation) [mmHg]	-7.31 (12.53)	-7.65 (7.49)	-6.67 (7.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan Potassium 0.1 to 1.4 mg/kg, Losartan Potassium 0.3 to 1.4 mg/kg, Losartan Potassium 0.7 to 1.4 mg/kg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.753
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.22
	Confidence Interval	(2-Sided) 95%; -6.45 to 8.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Mean Change From Baseline in Diastolic Blood Pressure
Description	Sitting BP (or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Diastolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.
Time Frame	Baseline and Day 21

Outcome Measure Data

Analysis Population Description

Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation

Arm/Group Title	Losartan Potassium 0.1 to 1.4 mg/kg	Losartan Potassium 0.3 to 1.4 mg/kg	Losartan Potassium 0.7 to 1.4 mg/kg
Arm/Group Description	Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved	Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved	Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
Measure Participants	32	34	33
Mean (Standard Deviation) [mmHg]	-8.25 (11.76)	-5.15 (8.06)	-6.73 (8.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan Potassium 0.1 to 1.4 mg/kg, Losartan Potassium 0.3 to 1.4 mg/kg, Losartan Potassium 0.7 to 1.4 mg/kg
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.643
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.81
	Confidence Interval	(2-Sided) 95%; -5.90 to 9.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)
Time Frame	up to 12 weeks (Base Study); up to 24 months (Extension)

Outcome Measure Data

Analysis Population Description

All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.

Arm/Group Title	Base Study-Losartan Potassium 0.1 mg/kg	Base Study-Losartan Potassium 0.3 mg/kg	Base Study-Losartan Potassium 0.7 mg/kg	Base Study-Losartan Potassium 1.4 mg/kg	Extension-Losartan Potassium
Arm/Group Description	Open-label Losartan 0.1 mg/kg/day	Open-label Losartan 0.3 mg/kg/day	Open-label Losartan 0.7 mg/kg/day	Open-label losartan 1.4 mg/kg/day	Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
Measure Participants	34	54	63	33	90
Clinical Adverse Event	21 63.6%	30 88.2%	36 105.9%	22 21.8%	75 NaN
Laboratory Adverse Event	1 3%	1 2.9%	0 0%	0 0%	5 NaN

4. Primary Outcome

Title	Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event
Time Frame	up to 12 weeks (Base Study); up to 24 months (Extension)

Outcome Measure Data

Analysis Population Description

All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.

Arm/Group Title	Base Study-Losartan Potassium 0.1 mg/kg	Base Study-Losartan Potassium 0.3 mg/kg	Base Study-Losartan Potassium 0.7 mg/kg	Base Study-Losartan Potassium 1.4 mg/kg	Extension-Losartan Potassium
Arm/Group Description	Open-label Losartan 0.1 mg/kg/day	Open-label Losartan 0.3 mg/kg/day	Open-label Losartan 0.7 mg/kg/day	Open-label losartan 1.4 mg/kg/day	Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
Measure Participants	34	54	63	33	90
Clinical Adverse Event	0 0%	0 0%	0 0%	0 0%	1 NaN
Laboratory Adverse Event	0 0%	0 0%	0 0%	0 0%	0 NaN

Adverse Events

Time Frame	up to 12 weeks (Base Study); up to 24 months (Extension)
Adverse Event Reporting Description	Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
Arm/Group Title	Base Study-Losartan Potassium 0.1 mg/kg/Day		Base Study-Losartan Potassium 0.3 mg/kg/Day		Base Study-Losartan Potassium 0.7 mg/kg/Day		Base Study-Losartan 1.4 mg/kg/Day		Extension-Losartan 0.1 mg/kg/Day		Extension-Losartan 0.3 mg/kg/Day		Extension-Losartan 0.7 mg/kg/Day		Extension-Losartan 1.4 mg/kg/Day
Arm/Group Description
All Cause Mortality
	Base Study-Losartan Potassium 0.1 mg/kg/Day		Base Study-Losartan Potassium 0.3 mg/kg/Day		Base Study-Losartan Potassium 0.7 mg/kg/Day		Base Study-Losartan 1.4 mg/kg/Day		Extension-Losartan 0.1 mg/kg/Day		Extension-Losartan 0.3 mg/kg/Day		Extension-Losartan 0.7 mg/kg/Day		Extension-Losartan 1.4 mg/kg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Base Study-Losartan Potassium 0.1 mg/kg/Day		Base Study-Losartan Potassium 0.3 mg/kg/Day		Base Study-Losartan Potassium 0.7 mg/kg/Day		Base Study-Losartan 1.4 mg/kg/Day		Extension-Losartan 0.1 mg/kg/Day		Extension-Losartan 0.3 mg/kg/Day		Extension-Losartan 0.7 mg/kg/Day		Extension-Losartan 1.4 mg/kg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/34 (8.8%)		2/54 (3.7%)		2/63 (3.2%)		0/33 (0%)		3/15 (20%)		5/28 (17.9%)		2/31 (6.5%)		5/42 (11.9%)
Gastrointestinal disorders
Enteritis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Gastritis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
General disorders
Asthenia	1/34 (2.9%)	1	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Infections and infestations
Adenoiditis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	1/31 (3.2%)	1	0/42 (0%)	0
Bronchopneumonia	0/34 (0%)	0	0/54 (0%)	0	1/63 (1.6%)	1	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Conjunctivitis bacterial	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Gastroenteritis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	2/28 (7.1%)	2	1/31 (3.2%)	1	1/42 (2.4%)	1
Laryngitis	0/34 (0%)	0	1/54 (1.9%)	1	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Nasopharyngitis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Pneumonia	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	0/31 (0%)	0	1/42 (2.4%)	1
Pyelonephritis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	0/31 (0%)	0	1/42 (2.4%)	1
Pyelonephritis acute	1/34 (2.9%)	1	0/54 (0%)	0	1/63 (1.6%)	1	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	1/31 (3.2%)	2	0/42 (0%)	0
Salmonellosis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Sepsis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	0/31 (0%)	0	1/42 (2.4%)	1
Sinusitis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	0/31 (0%)	0	1/42 (2.4%)	1
Upper respiratory tract infection	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	0/31 (0%)	0	1/42 (2.4%)	1
Upper respiratory tract infection bacterial	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Urinary tract infection	1/34 (2.9%)	1	1/54 (1.9%)	1	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	1/31 (3.2%)	1	1/42 (2.4%)	1
Injury, poisoning and procedural complications
Thermal burn	1/34 (2.9%)	1	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Toxicity to various agents	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	1/31 (3.2%)	1	0/42 (0%)	0
Metabolism and nutrition disorders
Dehydration	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	1/28 (3.6%)	2	0/31 (0%)	0	0/42 (0%)	0
Metabolic acidosis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	1/28 (3.6%)	1	0/31 (0%)	0	0/42 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nephroblastoma	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	1/28 (3.6%)	1	0/31 (0%)	0	0/42 (0%)	0
Psychiatric disorders
Psychomotor retardation	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	1/28 (3.6%)	1	0/31 (0%)	0	0/42 (0%)	0
Renal and urinary disorders
Renal failure acute	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	0/31 (0%)	0	1/42 (2.4%)	1
Renal impairment	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	1/28 (3.6%)	1	0/31 (0%)	0	0/42 (0%)	0
Ureteric stenosis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	1/28 (3.6%)	1	0/31 (0%)	0	0/42 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pleural effusion	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	0/31 (0%)	0	1/42 (2.4%)	1
Other (Not Including Serious) Adverse Events
	Base Study-Losartan Potassium 0.1 mg/kg/Day		Base Study-Losartan Potassium 0.3 mg/kg/Day		Base Study-Losartan Potassium 0.7 mg/kg/Day		Base Study-Losartan 1.4 mg/kg/Day		Extension-Losartan 0.1 mg/kg/Day		Extension-Losartan 0.3 mg/kg/Day		Extension-Losartan 0.7 mg/kg/Day		Extension-Losartan 1.4 mg/kg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/34 (44.1%)		22/54 (40.7%)		23/63 (36.5%)		17/33 (51.5%)		12/15 (80%)		20/28 (71.4%)		20/31 (64.5%)		28/42 (66.7%)
Eye disorders
Conjunctivitis	0/34 (0%)	0	2/54 (3.7%)	2	1/63 (1.6%)	1	0/33 (0%)	0	2/15 (13.3%)	2	0/28 (0%)	0	2/31 (6.5%)	2	1/42 (2.4%)	2
Gastrointestinal disorders
Abdominal pain	2/34 (5.9%)	2	1/54 (1.9%)	1	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	1/28 (3.6%)	1	1/31 (3.2%)	1	1/42 (2.4%)	1
Constipation	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	1/28 (3.6%)	1	0/31 (0%)	0	0/42 (0%)	0
Diarrhoea	2/34 (5.9%)	2	3/54 (5.6%)	3	4/63 (6.3%)	4	2/33 (6.1%)	2	3/15 (20%)	4	3/28 (10.7%)	5	5/31 (16.1%)	5	6/42 (14.3%)	8
Vomiting	1/34 (2.9%)	1	1/54 (1.9%)	1	1/63 (1.6%)	1	1/33 (3%)	1	0/15 (0%)	0	1/28 (3.6%)	7	2/31 (6.5%)	2	3/42 (7.1%)	3
General disorders
Pyrexia	3/34 (8.8%)	3	4/54 (7.4%)	6	3/63 (4.8%)	3	1/33 (3%)	1	1/15 (6.7%)	1	4/28 (14.3%)	5	2/31 (6.5%)	2	4/42 (9.5%)	10
Immune system disorders
Seasonal allergy	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Infections and infestations
Acute sinusitis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	1/28 (3.6%)	1	0/31 (0%)	0	0/42 (0%)	0
Acute tonsillitis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	2/15 (13.3%)	2	1/28 (3.6%)	1	1/31 (3.2%)	1	0/42 (0%)	0
Bronchitis	0/34 (0%)	0	2/54 (3.7%)	2	0/63 (0%)	0	1/33 (3%)	1	0/15 (0%)	0	2/28 (7.1%)	3	0/31 (0%)	0	2/42 (4.8%)	2
Ear infection	1/34 (2.9%)	1	0/54 (0%)	0	1/63 (1.6%)	1	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	1/31 (3.2%)	1	1/42 (2.4%)	1
Gastroenteritis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	3/42 (7.1%)	3
Gastroenteritis viral	0/34 (0%)	0	1/54 (1.9%)	1	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	2/28 (7.1%)	2	0/31 (0%)	0	0/42 (0%)	0
Impetigo	0/34 (0%)	0	1/54 (1.9%)	1	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	2/31 (6.5%)	2	0/42 (0%)	0
Laryngitis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	1/42 (2.4%)	1
Lower respiratory tract infection	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	1/28 (3.6%)	1	0/31 (0%)	0	1/42 (2.4%)	1
Nasopharyngitis	2/34 (5.9%)	2	7/54 (13%)	7	3/63 (4.8%)	3	2/33 (6.1%)	3	2/15 (13.3%)	3	4/28 (14.3%)	6	5/31 (16.1%)	6	2/42 (4.8%)	2
Oral herpes	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	1/31 (3.2%)	1	0/42 (0%)	0
Otitis media acute	0/34 (0%)	0	1/54 (1.9%)	1	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	1/28 (3.6%)	1	2/31 (6.5%)	2	2/42 (4.8%)	3
Pharyngitis	3/34 (8.8%)	3	2/54 (3.7%)	2	1/63 (1.6%)	1	1/33 (3%)	1	4/15 (26.7%)	5	1/28 (3.6%)	1	0/31 (0%)	0	1/42 (2.4%)	1
Respiratory tract infection	2/34 (5.9%)	2	1/54 (1.9%)	1	5/63 (7.9%)	6	3/33 (9.1%)	3	2/15 (13.3%)	2	3/28 (10.7%)	3	3/31 (9.7%)	6	5/42 (11.9%)	13
Rhinitis	1/34 (2.9%)	2	3/54 (5.6%)	3	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	1/28 (3.6%)	4	1/31 (3.2%)	1	0/42 (0%)	0
Sinusitis	0/34 (0%)	0	0/54 (0%)	0	1/63 (1.6%)	1	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	2/31 (6.5%)	2	5/42 (11.9%)	6
Tonsillitis	1/34 (2.9%)	1	0/54 (0%)	0	0/63 (0%)	0	1/33 (3%)	1	2/15 (13.3%)	2	1/28 (3.6%)	2	1/31 (3.2%)	1	2/42 (4.8%)	2
Upper respiratory tract infection	1/34 (2.9%)	1	3/54 (5.6%)	3	2/63 (3.2%)	3	0/33 (0%)	0	1/15 (6.7%)	1	4/28 (14.3%)	4	3/31 (9.7%)	8	4/42 (9.5%)	4
Urinary tract infection	2/34 (5.9%)	3	2/54 (3.7%)	2	4/63 (6.3%)	4	4/33 (12.1%)	4	0/15 (0%)	0	1/28 (3.6%)	1	3/31 (9.7%)	12	7/42 (16.7%)	13
Viral infection	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	1/33 (3%)	1	0/15 (0%)	0	2/28 (7.1%)	2	0/31 (0%)	0	1/42 (2.4%)	1
Injury, poisoning and procedural complications
Animal bite	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	2/28 (7.1%)	3	1/31 (3.2%)	1	0/42 (0%)	0
Ligament rupture	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Investigations
Protein urine present	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	1/28 (3.6%)	1	2/31 (6.5%)	2	1/42 (2.4%)	1
Red blood cell count decreased	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	2/31 (6.5%)	2	0/42 (0%)	0
Urine leukocyte esterase positive	0/34 (0%)	0	1/54 (1.9%)	1	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	1/28 (3.6%)	1	2/31 (6.5%)	2	0/42 (0%)	0
White blood cells urine positive	0/34 (0%)	0	1/54 (1.9%)	1	0/63 (0%)	0	0/33 (0%)	0	0/15 (0%)	0	0/28 (0%)	0	2/31 (6.5%)	2	0/42 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer stage III	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Nervous system disorders
Headache	0/34 (0%)	0	1/54 (1.9%)	1	1/63 (1.6%)	1	1/33 (3%)	1	0/15 (0%)	0	3/28 (10.7%)	3	0/31 (0%)	0	1/42 (2.4%)	1
Renal and urinary disorders
Enuresis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Nephrocalcinosis	0/34 (0%)	0	0/54 (0%)	0	0/63 (0%)	0	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	2/34 (5.9%)	2	2/54 (3.7%)	3	2/63 (3.2%)	2	5/33 (15.2%)	5	1/15 (6.7%)	1	1/28 (3.6%)	1	3/31 (9.7%)	3	5/42 (11.9%)	9
Rhinitis allergic	0/34 (0%)	0	0/54 (0%)	0	1/63 (1.6%)	1	1/33 (3%)	1	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Skin and subcutaneous tissue disorders
Rash	0/34 (0%)	0	2/54 (3.7%)	2	1/63 (1.6%)	1	2/33 (6.1%)	5	2/15 (13.3%)	2	1/28 (3.6%)	1	0/31 (0%)	0	4/42 (9.5%)	4
Vascular disorders
Hypertension	0/34 (0%)	0	1/54 (1.9%)	1	1/63 (1.6%)	1	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0
Hypotension	0/34 (0%)	0	0/54 (0%)	0	1/63 (1.6%)	1	0/33 (0%)	0	1/15 (6.7%)	1	0/28 (0%)	0	0/31 (0%)	0	0/42 (0%)	0

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

Subsequent to the multicenter publication, or 24 months after completion of the study, whichever comes first, an investigator and/or his/her colleagues may publish the results for their study site independently. 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.