The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term (6 months, core and extension protocols) use of valsartan in children 1 to 5 years old with hypertension...
Date First Received: April 5, 2007
Last Updated: June 13, 2008
Verified by: Novartis, June 2008
Clinical Trial Phase: Phase 3 | Start Date: April 2007
Overall Status: Recruiting
Estimated Enrollment: 68
Brief Summary
Official Title: “An Open Label Extension Study to Evaluate Safety, Tolerability, and Efficacy of 18 Weeks of Valsartan Treatment in Children 1-5 Years Old With Hypertension”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term (6 months, core and extension protocols) use of valsartan in children 1 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: October 2010
Intervention(s) in this Clinical Trial
- Drug: Valsartan
Outcome Measures for this Clinical Trial
Primary Measures
- 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
Secondary Measures
- This section is Not applicable
- Time Frame: this section is not applicable
- Time Frame: this section is not applicable
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: 1 Year
Maximum Age for this Clinical Trial: 5 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Sponsor GmbH
Overall Contact: Novartis Pharmaceuticals 862-778-8300
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
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
Clinical Trials Authorship and Review
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