EUCTR2006-005261-19-BEActive, not recruitingNot Applicable
A randomized, multicenter, double-blind, 6 week study to evaluate the dose response of valsartan on blood pressure reduction in children 6 months-5 years old with hypertension, followed by a 2 week placebo withdrawal period
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 75
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 6 months 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 (Appendix 3). For children under 1 year of age see appendix 4. For all patients, mean seated systolic blood pressure should be equal to or greater than 95th percentile at randomization.
- •6. Patients with uncontrolled blood pressure, receiving background antihypertensive
- •therapy, may continue on this therapy provided there is no change in dosing
- •7. Parent(s)/guardian(s) are able to follow verbal and/or written instructions in the
- •local language.
- •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
- •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 Appendix 3. For children under 1 year of age see Appendix 4.
- •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:
- •AST/SGOT or ALT/SGPT > 3 times the upper limit of the reference range
- •Total bilirubin > 2 times the upper limit of the reference range
- •Creatinine clearance < 30 mL/min/1.73m² (calculated using Modified Schwartz
- •formula to estimate glomerular filtration rate [GFR], see section 7.5.5 for
- •formula, based on the serum creatinine concentration obtained at Visit 1
- •(Screening).
- •WBC count < 3000/mm³
- •Platelet count < 100,000/mm³
- •Serum potassium > upper limit of the reference range
- •5. Patients that demonstrate clinically significant ECG abnormalities other than
- •those associated with left ventricular hypertrophy and AV block controlled with a
- •6. Patients that have coarctation of the aorta with a gradient of = 30 mm Hg, or
- •renal artery stenosis.
- •7. Patient that has any clinically significant unstable medical condition or chronic
- •disease that would put the patient at risk of experiencing an adverse event
- •associated with the expected pharmacodynamic effects of the study medication.
- •8. Patient that has experienced a significant clinical illness within 10 days prior to
- •baseline visit.
- •9. Patient that is known to have tested positive for the hepatitis B surface antigen
- •or hepatitis C antibody.
- •10. Patient that is known to have tested seropositive for the human
- •immunodeficiency virus (HIV) or patient is concomitantly receiving anti-retroviral
- •11. Patients that had a previous solid organ transplantation < 1 year prior to Visit 1 is excluded. Patient whose transplantation was performed = 1 year prior to Visit 1 must be on stable doses of immunosuppresive therapy and deemed clinically stable by the clinician, to be enrolled. Stable doses of immunosuppressive therapy are defined as no change in frequency or total daily doses of immunosuppressive therapy for at least 3 months prior to screening . Doses of immunosuppressive therapy must be maintained throughout Periods 1 & 2 of the study.
Investigators
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