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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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: April 5, 2007
Last updated: November 16, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Drug: Valsartan
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Safety and tolerability of valsartan in children 6 months - 5 years old with hypertension. [ Time Frame: at ever visit ]

Enrollment: 66
Study Start Date: April 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valsartan 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.


Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00457626

  Show 36 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00457626     History of Changes
Other Study ID Numbers: CVAL489K2303E1
2006-005473-21 ( EudraCT Number )
Study First Received: April 5, 2007
Last Updated: November 16, 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
High Blood Pressure

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017