EUCTR2006-005473-21-DE
Active, not recruiting
Not Applicable
An open label extentsion study to evaluate safety, tolerability, and efficacy of 18 weeks of valsartan treatment in children 1-5 years old with hypertension.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 68
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who qualified and entered core study CVAL489K2303
- •2\. 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\.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. Patients who did not complete period 1 of the core study.
- •2\. Patients who were re\-reandomized in period 2 of core study but did not continue
- •for \=3 days in period 2 of the core study.
- •3\. Patients who experienced any adverse events considered serious or drug related
- •in study CVAL489K3203\.
- •4\. Patients excluded from core protocol CVAL489K2303\.
Outcomes
Primary Outcomes
Not specified
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