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An Open Label Extension Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00457626
First Posted: April 6, 2007
Last Update Posted: November 18, 2016
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 )
April 5, 2007
April 6, 2007
November 18, 2016
April 2007
May 2009   (Final data collection date for primary outcome measure)
Safety and tolerability of valsartan in children 6 months - 5 years old with hypertension. [ Time Frame: at ever visit ]
Long term Safety and tolerability of Valsartan assessed by observing the patients in the trial for a period of 6 months. All serious adverse events and adverse events will be recorded in this period
Complete list of historical versions of study NCT00457626 on ClinicalTrials.gov Archive Site
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An Open Label Extension 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
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypertension
Drug: Valsartan
All patients started with dose 1 mg/kg once daily for first 2 weeks, up-titration to 2mg/kg (then to 4mg/kg) depending on MSSBP.
Experimental: Valsartan
Intervention: Drug: Valsartan
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
May 2009
May 2009   (Final data collection date for primary outcome measure)

Inclusion criteria

  • Patients who qualified and entered the core study.
  • Patients 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

  • Patients who did not complete period 1 of the core study.
  • Patients who were re-randomized in period 2 of core study but did not continue for => 3 days in period 2 of the core study.
  • Patients who experienced any adverse events considered serious or drug related in the core study.
  • Patients excluded from the core study.
Sexes Eligible for Study: All
6 Months to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Brazil,   France,   Hungary,   India,   Italy,   Poland,   South Africa,   Turkey,   United States
Germany,   Sweden,   Switzerland
 
NCT00457626
CVAL489K2303E1
2006-005473-21 ( EudraCT Number )
No
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP