Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure

This study has been completed.

Study NCT00433836 Information provided by Novartis

First Received on February 8, 2007. Last Updated on April 19, 2011 History of Changes

Results First Received: December 8, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: Valsartan Drug: Enalapril

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Valsartan	Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Enalapril	Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.

Participant Flow: Overall Study

	Valsartan	Enalapril
STARTED	151	149
COMPLETED	138	143
NOT COMPLETED	13	6
Adverse Event	7	0
Lost to Follow-up	3	0
Withdrawal by Subject	2	1
Unsatisfactory therapeutic effect	1	1
Protocol Violation	0	2
Condition no longer requires study drug	0	1
Abnormal laboratory values	0	1

Baseline Characteristics

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Reporting Groups

	Description
Valsartan	Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Enalapril	Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.

Baseline Measures

	Valsartan	Enalapril	Total
Number of Participants [units: participants]	151	149	300
Age [units: years] Mean ± Standard Deviation	12.7 ± 2.93	13.0 ± 2.94	12.9 ± 2.93
Gender [units: participants]
Female	65	44	109
Male	86	105	191

Outcome Measures

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1. Primary:

Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline and Week 12 ]

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2. Secondary:

Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline and Week 12 ]

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3. Secondary:

Decrease in MSSBP to < 95th Percentile for Age, Gender and Height [ Time Frame: at week 12 ]

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4. Secondary:

Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients [ Time Frame: Baseline and Week 8 ]

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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. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00433836 History of Changes
Other Study ID Numbers:	CVAL489K2302
Study First Received:	February 8, 2007
Results First Received:	December 8, 2010
Last Updated:	April 19, 2011
Health Authority:	United States: Food and Drug Administration; Belgium: Federal Public Service, Health, Food Chain Safety & Environment; Czech Republic: State Institute for Drug Control; France: Agence Francaise de Sécurite Sanitair des produits de santé; Germany: BfArM; Hungary: National Institute of Pharmacy; Italy: Italian Medicines Agency; Poland: The Office for Registration of Medicinal Products; Poland: Medical Devices and Biocidal Products; Sweden: Läkemedelsverket Medical Products Agency; Brazil: National Health Surveillance Agency; India: Central Drug Standard Control Organisation; Turkey: Turkey Ministry of Health