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Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01617681
First Posted: June 12, 2012
Last Update Posted: September 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
Results First Submitted: July 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Pediatric Hypertension With or Without CKD
Interventions: Drug: VAL489
Drug: VAL489 matching placebo

  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
Overall, 156 patients were screened, of which 127 patients were enrolled in the double blind period 1 of the study. A total of 120 patients (94.5%) completed Period 1 and entered Open Label Period 2.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Parallel= Period 1 (Double Blind phase) Single= Period 2 (Open Label phase)

Reporting Groups
  Description
CKD Patients Valsartan 0.25 mg/kg CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
CKD Patients Valsartan 4 mg/kg CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
Non-CKD Patients Valsartan 0.25 mg/kg Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
Non-CKD Patients Valsartan 4 mg/kg Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
Valsartan 1 mg/kg (Period 2) Open-label (Period 2) valsartan will be optionally titrated from 1 mg/kg to 2 mg/kg. Valsartan will continue to be optionally up titrated in 1 mg/kg increments every 4 weeks until maximum dose of 4 mg/kg is achieved. Duration 20 weeks.

Participant Flow for 2 periods

Period 1:   Period 1 Double Blind
    CKD Patients Valsartan 0.25 mg/kg   CKD Patients Valsartan 4 mg/kg   Non-CKD Patients Valsartan 0.25 mg/kg   Non-CKD Patients Valsartan 4 mg/kg   Valsartan 1 mg/kg (Period 2)
STARTED   32   31   33   31   0 
Full Analysis Set (FAS)   31   31   33   31   0 
COMPLETED   29   30   32   29   0 
NOT COMPLETED   3   1   1   2   0 
Adverse Event                2                0                0                2                0 
Withdrawal by Subject                1                1                1                0                0 

Period 2:   Period 2 Open Label
    CKD Patients Valsartan 0.25 mg/kg   CKD Patients Valsartan 4 mg/kg   Non-CKD Patients Valsartan 0.25 mg/kg   Non-CKD Patients Valsartan 4 mg/kg   Valsartan 1 mg/kg (Period 2)
STARTED   0   0   0   0   120 
COMPLETED   0   0   0   0   114 
NOT COMPLETED   0   0   0   0   6 
Adverse Event                0                0                0                0                3 
Withdrawal by Subject                0                0                0                0                3 



  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.
No text entered.

Reporting Groups
  Description
CKD Patients Valsartan 0.25 mg/kg CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
CKD Patients Valsartan 4 mg/kg CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
Non-CKD Patients Valsartan 0.25 mg/kg Non-CKD patients: Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)
Non-CKD Patients Valsartan 4 mg/kg Non-CKD patients: Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)
Total Total of all reporting groups

Baseline Measures
   CKD Patients Valsartan 0.25 mg/kg   CKD Patients Valsartan 4 mg/kg   Non-CKD Patients Valsartan 0.25 mg/kg   Non-CKD Patients Valsartan 4 mg/kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   31   33   31   127 
Age 
[Units: Years]
Mean (Standard Deviation)
 2.99  (1.47)   2.72  (1.33)   3.7  (1.51)   3.62  (1.36)   3.26  (1.466) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      12  37.5%      8  25.8%      14  42.4%      13  41.9%      47  37.0% 
Male      20  62.5%      23  74.2%      19  57.6%      18  58.1%      80  63.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      12  37.5%      16  51.6%      14  42.4%      15  48.4%      57  44.9% 
Not Hispanic or Latino      20  62.5%      15  48.4%      19  57.6%      16  51.6%      70  55.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
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1.  Primary:   Change From Baseline in Mean Systolic Blood Pressure (MSBP) at Week 6 Endpoint   [ Time Frame: Baseline, week 6 ]

2.  Secondary:   Change From Baseline in Mean Diastolic Blood Pressure (MDBP) at Week 6   [ Time Frame: Baseline, Week 6 ]

3.  Secondary:   Patients Achieving <90th Percentile for Age, Gender and Height at Week 6 Endpoint in Both MSBP and MDBP   [ Time Frame: Week 6 ]

4.  Secondary:   CKD Patients Achieving Urine Albumin Creatinine Ratio Percentage Reduction (UACR) >=25% at Week 6   [ Time Frame: Week 6 weeks ]


  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
No text entered.


  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: 8627788300
e-mail: Novartis.email@novartis.com



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01617681     History of Changes
Other Study ID Numbers: CVAL489K2306
2011-005991-40 ( EudraCT Number )
First Submitted: June 6, 2012
First Posted: June 12, 2012
Results First Submitted: July 24, 2017
Results First Posted: September 27, 2017
Last Update Posted: September 27, 2017