Clinical trial NCT00457626: A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Children
pediatrics
High Blood Pressure
Hypertension
Valsartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-04-06
Enrollment: 66
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
timeFrame: Baseline to Week 26
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
timeFrame: Baseline to Week 26
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Week 8 to Week 26 of Extension Phase
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Norfolk
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Edegem
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Laeken
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Goiania
country: Brazil
facility: Novartis Investigative Site
state: GO
city: Recife
country: Brazil
facility: Novartis Investigative Site
state: PE
city: Curitiba
country: Brazil
facility: Novartis Investigative Site
state: PR
city: Marseille
country: France
facility: Novartis Investigative Site
city: Paris Cedex 19
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: Andh Prad
city: Mangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Indore
country: India
facility: Novartis Investigative Site
state: M.p.
city: Mumbai
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Chennai
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: New Delhi
country: India
facility: Novartis Investigative Site
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Palermo
country: Italy
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Szczecin
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Gezina
country: South Africa
facility: Novartis Investigative Site
state: Gauteng
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Potchefstroom
country: South Africa
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.