A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension

• Status: Completed
• Trial end date: 2009-05-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Valsartan

Criteria

Inclusion criteria

• Participants who qualified and entered the core study.

• Participants 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

• Participants who did not complete Period 1 of the core study.

• Participants who were re-randomized in Period 2 of core study but did not continue for => 3 days in Period 2 of the core study.

• Participants who experienced any adverse events considered serious or drug related in the core study.

• Participants excluded from the core study.