Clinical trial NCT00446511: Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension
Official title: An Extension to Study Protocol CVAL489K2302 to Evaluate the Long Term Safety, Tolerability and Efficacy of Valsartan in Children 6 to 17 Years of Age With Hypertension, Versus Enalapril Treatment for 14 Weeks, or Combined With Enalapril Versus Enalapril for 66 Weeks in Chronic Kidney Disease Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: children
pediatrics
high blood pressure
hypertension
valsartan
enalapril
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-03-13
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients With Adverse Events
timeFrame: Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)
Secondary outcomes:
measure: Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26
timeFrame: Core Baseline (Week 0) to Week 26
measure: Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26
timeFrame: Week 26
measure: Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20
timeFrame: Core Baseline (Week 0) to Week 20
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26
timeFrame: Core Baseline (Week 0) to Week 26
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Sites in USA
state: New Jersey
city: Belgium
country: Belgium
facility: Sites in Belgium
city: France
country: France
facility: Sites in France
city: Germany
country: Germany
facility: Sites in Germany
city: Hungary
country: Hungary
facility: Sites in Hungary
city: India
country: India
facility: Sites in India
city: Italy
country: Italy
facility: Sites in Italy
city: Poland
country: Poland
facility: Sites in Poland
city: Turkey
country: Turkey
facility: Sites in Turkey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References: