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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

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ClinicalTrials.gov Identifier: NCT00457626
Recruitment Status : Completed
First Posted : April 6, 2007
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Valsartan Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2007
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457626


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

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00457626     History of Changes
Other Study ID Numbers: CVAL489K2303E1
2006-005473-21 ( EudraCT Number )
First Posted: April 6, 2007    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Children
pediatrics
High Blood Pressure
Hypertension
Valsartan

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action