A multicenter, randomized, double-blind, parallel-group, evaluation of 12 weeks of valsartan compared to enalapril on sitting systolic blood pressure in children 6 to 17 years of age with hypertensio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

• Male or female, ages 6-17 at randomization, with a documented history of
hypertension
• Must be able to swallow a pill
• Must be = 18 kg or =160 kg at randomization (Visit 2)
• Must be able to safely wash out antihypertensive therapy
• MSSBP (mean of 3 measurements) must be = 95th percentile, for age, gender and
height, at Visit 2 (randomization), by office blood pressure measurement
• 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 to
them. (An assent will be required for some patients depending upon their age and
local requirements regarding assents)

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, refer to protocol

Patients with any of the following physiological states or concomitant medical conditions at the screening visit will be excluded from participation in the study
• 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. Patients
known to have active or chronic hepatitis will be excluded.
• 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]), based on the serum
creatinine concentration obtained at the screening visit
• WBC count <3000/mm³
• Platelet count <100,000/mm³
• Serum potassium >5.3 mEq/L
• Unilateral and bilateral renal artery stenosis
• Current diagnosis of heart failure (NYHA Class II-IV).
• MSSBP = 25% above the 95th percentile
• Patient that demonstrates clinically significant ECG abnormalities other than those
associated with left ventricular hypertrophy and concurrent potentially life
threatening arrhythmia or symptomatic arrhythmia. Patients with second or third
degree heart block without a pacemaker.
• Previous solid organ transplantation except renal, liver or heart transplantation.
Renal, liver or heart transplant must have occurred at least 6 months prior to
enrollment. Patient must be on stable doses of immunosuppressive therapy for 3
months and deemed clinically stable by the investigator.
• Seropositive for the human immunodeficiency virus (HIV) and patient is
noncomitantly receiving anti-retroviral therapy

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

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