Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics) - Study Results

Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics) (HIP)

This study has been completed.

Study NCT00690612 Information provided by AstraZeneca

First Received on June 2, 2008. Last Updated on July 7, 2011 History of Changes

Results First Received: August 31, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hypertension
Intervention:	Drug: candesartan cilexetil

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Hypertensive children aged 1 to <11 years who had participated in the 1-year study (Protocol 328, D2451C00002-NCT00244621). First patient enrolled 17 Sep 2007 and last patient completed 9 Sep 2009 at Pediatric clinics in Europe.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who had participated in the 1-year study (Protocol 328, D2451C00002-NCT00244621) and did not discontinue study due to a study drug-related adverse event (AE) and had an ongoing clinical indication for treatment with candesartan.

Reporting Groups

	Description
Atacand Candesartan Cilexetil	candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.

Participant Flow: Overall Study

	Atacand Candesartan Cilexetil
STARTED	35
COMPLETED	32
NOT COMPLETED	3
Adverse Event	1
Withdrawal by Subject	2

Baseline Characteristics

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Reporting Groups

	Description
Atacand Candesartan Cilexetil	candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.

Baseline Measures

	Atacand Candesartan Cilexetil
Number of Participants [units: participants]	35
Age [units: Years] Mean ± Standard Deviation
<=11 years	4.4 ± 1.6
Gender [units: participants]
Female	10
Male	25

Outcome Measures

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1. Primary:

Mean Change From Baseline to Final Visit in Systolic Blood Pressure (SBP). [ Time Frame: Every 3 months- baseline to final visit ]

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2. Primary:

Mean Change From Baseline to Final Visit in Diastolic Blood Pressure (DBP). [ Time Frame: every 3 months - baseline to final visit ]

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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
No text entered.

Results Point of Contact:

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

No publications provided

Responsible Party:	James Hainer, MD, Sr. Director - Medical Research, Study Team Physician, AstraZeneca, LP
ClinicalTrials.gov Identifier:	NCT00690612 History of Changes
Other Study ID Numbers:	D2451C00006
Study First Received:	June 2, 2008
Results First Received:	August 31, 2010
Last Updated:	July 7, 2011
Health Authority:	United States: Food and Drug Administration; Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Ukraine: State Pharmacological Center - Ministry of Health