Hypertension
Conditions
Interventions
Trade Name: Diovan 40 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Valsartan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that valsartan is not inferior to enalapril in the reduction of mean sitting systolic blood pressure (MSSBP) at week 12 from baseline (week 0) as measured by office blood pressure reading, in hypertensive children aged 6 to 17 years old with or without chronic kidney disease.;Secondary Objective: For full list, please refer to protocol To evaluate: - the effect of valsartan versus enalapril in reducing sitting diastolic blood pressure (MSDBP) after 12 weeks of treatment from baseline as measured by office blood pressure measurement in hypertensive children 6-17 years of age. - the percentage of children whose MSSBP decreases to < 95th percentile for age, gender, and height on valsartan vs. enalapril monotherapy at week 12. - the safety and tolerability of valsartan, in comparison with enalapril monotherapy in hypertensive children Exploratory Objective - Evaluate the percentage of patients with CKD on valsartan vs. enalapril who have urine protein/creatinine ratio (UPCR) reduced by = 25% from baseline to week 12. ;Primary end point(s): Change from baseline in MSSBP (mean sitting systolic blood pressure) The primary analysis is for change from baseline at endpoint. Baseline is defined as the Week 0 value. Endpoint is defined as the Week 12 value or the last post-baseline observation carried forward (LOCF). | — |
Countries
Belgium, Czech Republic, France, Hungary, Italy, Sweden, United Kingdom
Outcome results
None listed