Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension

Novartis Pharmaceuticals250 enrolled

Overview

The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

250

Conditions

Hypertension

Interventions

ValsartanDRUG

Valsartan (80, 160, and 320 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.

EnalaprilDRUG

Enalapril (10, 20, and 40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.

placebo matched to enalaprilDRUG

Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Successful completion of 12 weeks of double-blind treatment in core protocol CVAL489K2302. * Patients participating in study CVAL489K2302 who may have discontinued prematurely due to uncontrolled hypertension defined as MSSBP \> 20%, but \< 25% above the 95th percentile for age, gender, and height after visit 5, qualifies a patient for entry into this extension study. Exclusion Criteria: * Renal artery stenosis. * Current diagnosis of heart failure (NYHA Class II-IV). * Second or third degree heart block without a pacemaker. * Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. * Clinically significant valvular heart disease. * Patient that demonstrates clinically significant ECG abnormalities other than those associated with left ventricular hypertrophy and AV block controlled with 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. * Patients who experienced any adverse events considered serious and drug related in protocol CVAL489K2302. Other protocol-defined inclusion/exclusion criteria applied to the study.

Locations (9)

Sites in USA

East Hanover, New Jersey, United States

Sites in Belgium

Belgium, Belgium

Sites in France

France, France

Sites in Germany

Germany, Germany

Outcomes

Primary Outcomes

Number of Patients With Adverse Events

Time frame: Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)

Secondary Outcomes

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26

After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure.

Time frame: Core Baseline (Week 0) to Week 26

Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26

Systolic and diastolic blood pressure (BP) control was defined as msSBP and msDBP \< 95th percentile for gender, age, and height. After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.

Time frame: Week 26

Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20

24-hour ambulatory blood pressure monitoring (ABPM) was conducted once during the extension in a subset of patients at selected centers. For all patients who completed a qualifying ABPM at baseline, an ABPM was to be performed at Week 20. The ABPM monitor was placed on the non-dominant arm.

Time frame: Core Baseline (Week 0) to Week 20

Data from ClinicalTrials.gov

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