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)”

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

Primary Measures

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

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

Lead Sponsor: Novartis Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

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