EUCTR2006-005261-19-SE
Active, not recruiting
Not Applicable
A randomized, multicenter, double-blind, 6 week study to evaluate the dose response of valsartan on blood pressure reduction in children 1-5 years old with hypertension, followed by a 2 week placebo withdrawal period
ConditionsHypertension
DrugsDiovan 160
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 75
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients who are eligible and able to participate in the study and whose parent
- •(s)/guardian(s) consent in writing (written informed consent) to their doing so
- •after the purpose and nature of the investigation has been clearly explained.
- •2\. Male or female between the ages of 1 to 5 years, at visit 1 with a documented
- •history of hypertension.
- •3\. Must be able to swallow the liquid formulation of the study medication
- •4\. Must be \= 8 kg or \= 40 kg
- •5\. Patients, either naïve or treated, must have a documented history of a mean
- •seated systolic blood pressure (mean of three measurements), equal to or
- •greater than 95th percentile for age, gender and height (Appendix 3\).
Exclusion Criteria
- •For full list, please refer to protocol.
- •1\. Patients whose mean seated systolic blood pressure (mean of three
- •measurements), at the baseline visit (Visit \# 2\) is \= 25% higher than the 95th
- •percentile for age, gender and height see Appendix 3\.
- •2\. Physical examination of patient demonstrates abnormalities that would make
- •this study medically hazardous to the patient.
- •3\. Patients with background ARB therapy.
- •4\. Patients that demonstrate any clinically significant abnormalities or clinically
- •noteworthy abnormal laboratory values (other than those relating to renal
- •function), including but not limited to the following:
Outcomes
Primary Outcomes
Not specified
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