Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension

This study has been completed.

Study NCT00446511 Information provided by Novartis

First Received on March 9, 2007. Last Updated on June 30, 2011 History of Changes

Results First Received: January 11, 2011

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 Drug: placebo matched to enalapril Drug: placebo matched to valsartan

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
CKD Patients: Valsartan+Enalapril	Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
CKD Patients: Enalapril	Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
Non-CKD Patients: Valsartan	Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
Non-CKD Patients: Enalapril	Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.

Participant Flow: Overall Study

	CKD Patients: Valsartan+Enalapril	CKD Patients: Enalapril	Non-CKD Patients: Valsartan	Non-CKD Patients: Enalapril
STARTED	21	17	103	109
COMPLETED	11	15	96	103
NOT COMPLETED	10	2	7	6
Adverse Event	7	2	3	1
Protocol Violation	0	0	0	1
Withdrawal by Subject	0	0	0	3
Administrative Problems	3	0	4	1

Baseline Characteristics

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Reporting Groups

	Description
CKD Patients: Valsartan+Enalapril	Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
CKD Patients: Enalapril	Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
Non-CKD Patients: Valsartan	Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
Non-CKD Patients: Enalapril	Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.

Baseline Measures

	CKD Patients: Valsartan+Enalapril	CKD Patients: Enalapril	Non-CKD Patients: Valsartan	Non-CKD Patients: Enalapril	Total
Number of Participants [units: participants]	21	17	103	109	250
Age [units: years] Mean ± Standard Deviation	11.4 ± 3.40	12.1 ± 3.07	13.1 ± 2.75	13.3 ± 2.81	13.0 ± 2.89
Gender [units: participants]
Female	8	5	41	27	81
Male	13	12	62	82	169

Outcome Measures

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1. Primary:

Number of Patients With Adverse Events [ Time Frame: Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients) ]

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2. Secondary:

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26 [ Time Frame: Core Baseline (Week 0) to Week 26 ]

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3. Secondary:

Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26 [ Time Frame: Week 26 ]

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4. Secondary:

Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20 [ Time Frame: Core Baseline (Week 0) to Week 20 ]

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5. Secondary:

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26 [ Time Frame: Core Baseline (Week 0) to Week 26 ]

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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
Study was prolonged from 14 to 66 wks for CKD patients only. Most CKD patients completed the initial 14 wk extension period prior to amendment approval and the study was terminated prematurely with 3 CKD patients progressing to a maximum of Visit 13.

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:	NCT00446511 History of Changes
Other Study ID Numbers:	CVAL489K2302E1
Study First Received:	March 9, 2007
Results First Received:	January 11, 2011
Last Updated:	June 30, 2011
Health Authority:	United States: Food and Drug Administration; Belgium : Federal Public Service, Health, Food Chain Safety & Environment; France : Agence Francaise de Sécurite Sanitair des produits de santé; Germany : Federal Institute for Drugs and Medical Devices (BfArM); Hungary: National Institute of Pharmacy; Italy : Italian Medicines Agency; Poland : The Office for Registration of Medicinal Products,Medical Devices and Biocidal Products; India : Central Drug Standard Control Organization; Turkey : Turkey Ministry of Health