Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT00446511
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CKD patients: Enalapril placebo matched to valsartan - Non-CKD patients: Valsartan placebo matched to enalapril - Non-CKD patients: Enalapril Enalapril - Non-CKD patients: Enalapril placebo matched to valsartan - CKD patients: Valsartan+enalapril Valsartan - Non-CKD patients: Valsartan Valsartan - CKD patients: Valsartan+enalapril Enalapril - CKD patients: Enalapril Enalapril -
- Primary Outcome Measures
Name Time Method Number of Patients With Adverse Events Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)
- Secondary Outcome Measures
Name Time Method Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26 Core Baseline (Week 0) 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.
Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26 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.
Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20 Core Baseline (Week 0) to 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.
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26 Core Baseline (Week 0) 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.
Trial Locations
- Locations (9)
Sites in France
🇫🇷France, France
Sites in India
🇮🇳India, India
Sites in Poland
🇵🇱Poland, Poland
Sites in Belgium
🇧🇪Belgium, Belgium
Sites in Turkey
🇹🇷Turkey, Turkey
Sites in Germany
🇩🇪Germany, Germany
Sites in USA
🇺🇸East Hanover, New Jersey, United States
Sites in Italy
🇮🇹Italy, Italy
Sites in Hungary
ðŸ‡ðŸ‡ºHungary, Hungary