Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study population included male and female participants 1 to <6 years of age with mild to moderate hypertension. The participants were recruited during the time period from 04 November 2004 to 07 August 2008 at pediatric clinics in the USA, Puerto Rico and Europe.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One to 2 weeks following a screening evaluation, participants underwent a 1-week, single-blind, placebo run-in period to reduce the variability in the baseline blood pressure measurements and to stabilize any concurrent antihypertensive medications.

Reporting Groups

	Description
Atacand .05 mg	candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
Atacand .20 mg	candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
Atacand .40 mg	candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose

Participant Flow for 2 periods

	Atacand .05 mg	Atacand .20 mg	Atacand .40 mg
STARTED	29	32	32
COMPLETED	27	29	30
NOT COMPLETED	2	3	2
Lost to Follow-up	0	0	1
Withdrawal by Subject	0	1	0
Lack of Efficacy	0	1	0
Multiple Reasons	2	1	1

	Atacand .05 mg	Atacand .20 mg	Atacand .40 mg
STARTED	26[1]	29	30
COMPLETED	25	28	28
NOT COMPLETED	1	1	2
Lost to Follow-up	0	1	0
Withdrawal by Subject	1	0	0
Lack of Efficacy	0	0	0
Adverse Event	0	0	1
Moved abroad	0	0	1

Reporting Groups

	Description
Atacand .05 mg	candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
Atacand .20 mg	candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
Atacand .40 mg	candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose

Baseline Measures

	Atacand .05 mg	Atacand .20 mg	Atacand .40 mg	Total
Number of Participants   [units: participants]	29	32	32	93
Age, Customized   [units: Participants]
1 to <2 years	6	5	5	16
2 to <6 years	23	27	27	77
Gender   [units: Participants]
Female	11	10	12	33
Male	18	22	20	60

1.  Primary:

Mean Change From Baseline to Week 4 in Systolic Blood Pressure (SBP)   [ From randomisation to end of double-blind treatment (4 weeks) ]

2.  Secondary:

Mean Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)   [ From randomisation to end of double-blind treatment (4 weeks) ]

3.  Secondary:

Change in Albumin/Creatinine (A/C) Ratio for Each Assigned Dose Level From Baseline to Day 28   [ From randomisation to day 28 ]

4.  Secondary:

Change in Protein/Creatinine (P/C) Ratio for Each Assigned Dose Level From Baseline to Day 28   [ From randomisation to day 28 ]