Atacand Dose Ranging in Hypertensive Pediatric Subjects 1 Year to Less Than 6 Years of Age - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment
Condition:	Hypertension
Intervention:	Drug: candesartan cilexetil (Atacand)

Participant Flow

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

Period: Double-blind Treatment Period

	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

Period: Open-label Treatment Period

	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

[1]	One participant discontinued study due to Adverse Event after completing the double-blind period.

Baseline Characteristics

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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

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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Serious Adverse Events

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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

Serious Adverse Events

	Atacand .05 mg	Atacand .20 mg	Atacand .40 mg
Total, serious adverse events
# participants affected	6	5	4
Blood and lymphatic system disorders
Lymphadenitis ^†^A # participants affected / at risk	0/29 (0.00%)	1/32 (3.13%)	0/32 (0.00%)
Catheter Site Haematoma ^†^A # participants affected / at risk	1/29 (3.45%)	0/32 (0.00%)	0/32 (0.00%)
Catheter Site Necrosis ^†^A # participants affected / at risk	1/29 (3.45%)	0/32 (0.00%)	0/32 (0.00%)
Pyrexia ^†^A # participants affected / at risk	0/29 (0.00%)	1/32 (3.13%)	1/32 (3.13%)
Immune system disorders
Drug Hypersensitivity ^†^A # participants affected / at risk	0/29 (0.00%)	0/32 (0.00%)	1/32 (3.13%)
Infections and infestations
Bronchiolitis ^†^A # participants affected / at risk	1/29 (3.45%)	0/32 (0.00%)	0/32 (0.00%)
External Ear Cellulitis ^†^A # participants affected / at risk	1/29 (3.45%)	0/32 (0.00%)	0/32 (0.00%)
Pneumonia ^†^A # participants affected / at risk	1/29 (3.45%)	0/32 (0.00%)	0/32 (0.00%)
Pneumonia Parainfluenzae Viral ^†^A # participants affected / at risk	0/29 (0.00%)	1/32 (3.13%)	0/32 (0.00%)
Pyelonephritis ^†^A # participants affected / at risk	1/29 (3.45%)	0/32 (0.00%)	0/32 (0.00%)
Upper Respiratory Tract Infection ^†^A # participants affected / at risk	0/29 (0.00%)	1/32 (3.13%)	0/32 (0.00%)
Urinary Tract Infection ^†^A # participants affected / at risk	0/29 (0.00%)	2/32 (6.25%)	2/32 (6.25%)
Injury, poisoning and procedural complications
Post Procedural Haemorrhage ^†^A # participants affected / at risk	0/29 (0.00%)	1/32 (3.13%)	0/32 (0.00%)
Renal and urinary disorders
Glomerulonephritis Chronic ^†^A # participants affected / at risk	0/29 (0.00%)	0/32 (0.00%)	1/32 (3.13%)
Nephrotic Syndrome ^†^A # participants affected / at risk	1/29 (3.45%)	0/32 (0.00%)	0/32 (0.00%)
Vascular disorders
Vena Cava Thrombosis ^†^A # participants affected / at risk	1/29 (3.45%)	0/32 (0.00%)	0/32 (0.00%)

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA 11.0

Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com

No publications provided

Study ID Numbers:	D2451C00002, 328
Study First Received:	October 25, 2005
Results First Received:	August 7, 2009
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00244621 History of Changes
Health Authority:	United States: Food and Drug Administration