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.
Phase 1
- Conditions
- HypertensionMedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension
- Registration Number
- EUCTR2006-005473-21-FR
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 66
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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. ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method