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
- Conditions
- Hypertension
- Registration Number
- EUCTR2006-005260-88-SK
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
• 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
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
• GFR <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, bilateral and graft renal artery stenosis
• Current diagnosis of heart failure (NYHA Class II-IV).
• MSSBP = 25% above the 95th percentile
• Patient that demonstrate clinically significant ECG abnormalities such as concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. In addition patients with second or third degree heart block without a pacemaker. Patients with ECG abnormalities associated with left ventricular hypertrophy are permitted to enroll.
• Patients that have coarctation of the aorta with gradient of =30 mm Hg
• 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.
• Patient that is known to have tested 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