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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00433836
First received: February 8, 2007
Last updated: April 19, 2011
Last verified: April 2011
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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.
Total Total of all reporting groups

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 ]

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

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

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked 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.


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