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.
- Conditions
- Hypertension
- Registration Number
- EUCTR2006-005473-21-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 68
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method