Clinical trial NCT00433836: Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure
Official title: 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 Hypertension
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: 2007-02-12
Enrollment: 300
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 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender and height).


Eligibility criteria: Inclusion Criteria:

* Male or female, ages 6-17, with a documented history of hypertension
* Must be able to swallow a pill
* Must be ≥ 18 kg or ≤160 kg
* 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)

Exclusion Criteria:

* Renal artery stenosis
* Current diagnosis of heart failure (NYHA Class II-IV).
* MSSBP ≥ 25% above the 95th percentile
* 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.
* 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.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
timeFrame: Baseline and Week 12
measure: Decrease in MSSBP to < 95th Percentile for Age, Gender and Height
timeFrame: at week 12
measure: Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Sites in USA
state: New Jersey
city: Sites in Belgium
country: Belgium
facility: Sites in Belgium
city: Sites in France
country: France
facility: Sites in France
city: Sites in Germany
country: Germany
facility: Sites in Germany
city: Hungary
country: Hungary
facility: Sites in Hungary
city: Sites in India
country: India
facility: Sites in India
city: Sites in Italy
country: Italy
facility: Sites in Italy
city: Poland
country: Poland
facility: Sites in Poland
city: Slovakia
country: Slovakia
facility: Sites in Slovakia
city: Sites in Sweden
country: Sweden
facility: Sites in Sweden
city: Turkey
country: Turkey
facility: Sites in Turkey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: