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

• Conditions: Hypertension

• Registration Number: EUCTR2006-005261-19-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

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).
6. Patients with uncontrolled blood pressure, receiving background antihypertensive
therapy, may continue on this therapy provided there is no change in dosing
regimen.
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 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:
• 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. Patients with
ECG abnormalities associated with left ventricular hypertrophy are permitted to
enroll.
6. Patients that have coarctation of the aorta with a gradient of = 30 mm Hg.
7. Patient that has had a previous solid organ transplantation < 1 year ago. Patient
must be on stable doses of immunosuppressive therapy and deemed clinically
stable by the clinician. 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 and 2 of the study.
8. Unilateral, bilateral and graft renal artery stenosis.
9. 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.
10. Patient that has experienced a significant clinical illness within 10 days prior to
baseline visit.
11. Patient that is known to have tested positive for the hepatitis B surface antigen
or hepatitis C antibody.
12. Patient that is known to have tested seropositive for the human
immunodeficiency virus (HIV) or patient is concomitantly receiving anti-retroviral
therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified