A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension
An Open Label Extension Study to Evaluate Safety, Tolerability, and Efficacy of 18 Weeks of Valsartan Treatment in Children 6 Months-5 Years Old With Hypertension
2 other identifiers
interventional
66
10 countries
36
Brief Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hypertension
Started Apr 2007
Typical duration for phase_3 hypertension
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2007
CompletedFirst Posted
Study publicly available on registry
April 6, 2007
CompletedStudy Start
First participant enrolled
April 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2009
CompletedResults Posted
Study results publicly available
May 20, 2021
CompletedSeptember 5, 2021
September 1, 2021
2.1 years
April 5, 2007
April 28, 2021
September 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sitting systolic blood pressure (SSBP) measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement.
Baseline to Week 26
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three SDBP measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement.
Baseline to Week 26
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.
Week 8 to Week 26 of Extension Phase
Study Arms (1)
Valsartan Open Label
EXPERIMENTALExtemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg, escalated to 2 mg/kg or 4 mg/kg based on mean sitting systolic blood pressure (MSSBP) control after 2 weeks up to 18 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Participants who qualified and entered the core study.
- Participants who participated in the core study, completed Period 1 and were re-randomized in Period 2 and continued for at least 3 days in Period 2.
You may not qualify if:
- Participants who did not complete Period 1 of the core study.
- Participants who were re-randomized in Period 2 of core study but did not continue for =\> 3 days in Period 2 of the core study.
- Participants who experienced any adverse events considered serious or drug related in the core study.
- Participants excluded from the core study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Novartis Investigative Site
Hackensack, New Jersey, 07601, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, 19104, United States
Novartis Investigative Site
Norfolk, Virginia, 23510, United States
Novartis Investigative Site
Antwerp, 2020, Belgium
Novartis Investigative Site
Edegem, 2650, Belgium
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Laken, 1020, Belgium
Novartis Investigative Site
Liège, 4000, Belgium
Novartis Investigative Site
Goiânia, Goiás, 74605-050, Brazil
Novartis Investigative Site
Curitiba, Paraná, 80250-030, Brazil
Novartis Investigative Site
Recife, Pernambuco, 50070-050, Brazil
Novartis Investigative Site
Marseille, 13385, France
Novartis Investigative Site
Paris, 75935, France
Novartis Investigative Site
Toulouse, 31026, France
Novartis Investigative Site
Budapest, H-1083, Hungary
Novartis Investigative Site
Szeged, H-6720, Hungary
Novartis Investigative Site
Hyderabad, Andh Prad, 500033, India
Novartis Investigative Site
Mangalore, Karnataka, 575001, India
Novartis Investigative Site
Indore, M.P., 425001, India
Novartis Investigative Site
Mumbai, Maharashtra, 400026, India
Novartis Investigative Site
Chennai, Tamil Nadu, 600008, India
Novartis Investigative Site
New Delhi, 110 029, India
Novartis Investigative Site
Torino, TO, 10126, Italy
Novartis Investigative Site
Palermo, 90134, Italy
Novartis Investigative Site
Gdansk, 80-952, Poland
Novartis Investigative Site
Krakow, 30-663, Poland
Novartis Investigative Site
Lodz, 93-338, Poland
Novartis Investigative Site
Poznan, 60-572, Poland
Novartis Investigative Site
Szczecin, 70-410, Poland
Novartis Investigative Site
Warsaw, 04-730, Poland
Novartis Investigative Site
Gezina, Gauteng, 0084, South Africa
Novartis Investigative Site
Cape Town, 7505, South Africa
Novartis Investigative Site
Potchefstroom, South Africa
Novartis Investigative Site
Pretoria, 0002, South Africa
Novartis Investigative Site
Ankara, 06100, Turkey (Türkiye)
Novartis Investigative Site
Izmir, 35040, Turkey (Türkiye)
Related Publications (1)
Schaefer F, Coppo R, Bagga A, Senguttuvan P, Schlosshauer R, Zhang Y, Kadwa M. Efficacy and safety of valsartan in hypertensive children 6 months to 5 years of age. J Hypertens. 2013 May;31(5):993-1000. doi: 10.1097/HJH.0b013e32835f5721.
PMID: 23511339RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2007
First Posted
April 6, 2007
Study Start
April 9, 2007
Primary Completion
May 25, 2009
Study Completion
May 25, 2009
Last Updated
September 5, 2021
Results First Posted
May 20, 2021
Record last verified: 2021-09