An Open Label Extension to Study CVAL489K2303 to Evaluate the Long Term Use of Valsartan in 6 Months - 5 Year Old Hypertensive Children

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...

Date First Received: April 5, 2007

Last Updated: December 16, 2008

Verified by: Novartis, December 2008

Clinical Trial Phase: Phase 3 | Start Date: June 2007

Overall Status: Enrolling by invitation

Estimated Enrollment: 68

Brief Summary

Official Title: “An Extension Study to Evaluate Safety, Tolerability, and Efficacy of 18 Weeks of Valsartan Treatment in Children 6 Months-5 Years Old With Hypertension or 70 Weeks of Enalapril vs Valsartan + Enalapril Treatment in Patients With Chronic Kidney Disease (CKD)”

Condition Keyword(s):

Intervention(s):

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

  • Drug: Valsartan

Outcome Measures for this Clinical Trial

Primary Measures

  • Safety and tolerability of valsartan in children 6 months - 5 years old with hypertension.
    • Time Frame: at ever visit
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Patients who qualified and entered core study CVAL489K2303
  • Patients who participated in the core study CVAL489K2303, 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.
  • Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Months

Maximum Age for this Clinical Trial: 5 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Novartis Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00457626

Study ID Number: CVAL489K2303E1

ClinicalTrials.gov Identifier: NCT00457626

Health Authority: United States: Food and Drug Administration

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