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

This study has been completed.

Study NCT00244621 Information provided by AstraZeneca

First Received: October 25, 2005 Last Updated: August 7, 2009 History of Changes

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

Participant Flow

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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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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