Status:
COMPLETED
A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypertension
Eligibility:
All Genders
6-5 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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.
- Exclusion criteria
- 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.
Exclusion
Key Trial Info
Start Date :
April 9 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2009
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00457626
Start Date
April 9 2007
End Date
May 25 2009
Last Update
September 5 2021
Active Locations (36)
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1
Novartis Investigative Site
Hackensack, New Jersey, United States, 07601
2
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19104
3
Novartis Investigative Site
Norfolk, Virginia, United States, 23510
4
Novartis Investigative Site
Antwerp, Belgium, 2020