An extension to study protocol CVAL489K2302 to evaluate the long term safety, tolerability and efficacy of valsartan children 6 to 17 years of age with hypertension, versus enalapril treatment for 14 weeks, or combined with enalapril for 66 weeks in chronic kidney disease patients.
- Conditions
- Hypertension
- Registration Number
- EUCTR2006-005408-14-BE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 270
Please refer to CVAL489K2302 for complete details related to the inclusion and exclusion criteria for the core study.
Additional inclusion criteria:
- Successful completion of 12 weeks of double blind treatment in core protocol
CVAL489K2302
- Discontinueing prematurely from teh core CVAL489K2302 study due to
uncontrolled hypertension defined as; MSSBP>20%, but ><25% above the 95th
percentile for age, gender, and height after visit 5, qualifies a patient for entry into
this extension study.
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
Please refer to CVAL489K2302 for complete details related to the inclusion and exclusion criteria for the core study.
Additional exclusion criteria:-
- Patients who experienced any adverse events considered serious and drug
related in protocol CVAL489K2302 are exluded.
- Patients who live far from a site & have logistic difficulties in getting repeat serum potassium test performed whitin 1 week of first elevated values (K+> 5.3) will not be considered for enrollment in the study.
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