Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure

Condition(s) targeted: Hypertension

Intervention: Valsartan (Drug); Enalapril (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Sponsor GmbH

Overall contact:
Novartis Pharmaceuticals, Phone: 862-778-8300

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).

Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled 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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Reduction of mean sitting systolic blood pressure (MSSBP) at Week 12 from baseline

Secondary outcome:

Reduction of mean sitting diastolic blood pressure (MSDBP) at Week 12 from baseline

Decrease in MSSBP to < 95th percentile for age, gender and height at Week 12

Change in mean ambulatory systolic blood pressure and mean ambulatory diastolic blood pressure over 24 hours in subset of patients, Week 12 compared to baseline

Safety and tolerability of valsartan compared to enalapril

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

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

Novartis Pharmaceuticals, Phone: 862-778-8300

Sites in Argentina, Argentina, Argentina; Not yet recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111

Sites in Belgium, Sites in Belgium, Belgium; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111

Sites in Brazil, Sites in Brazil, Brazil; Not yet recruiting
Novartis Pharmaceuticials, Phone: 41 61 324 1111

Sites in Chile, Chile, Chile; Not yet recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111

Sites in Czech Republic, Czech Republic, Czech Republic; Not yet recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111

Sites in France, Sites in France, France; Not yet recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111

Sites in Germany, Sites in Germany, Germany; Not yet recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111

Sites in India, Sites in India, India; Not yet recruiting
Novartis Pharmaceuticials, Phone: 41 61 324 1111

Sites in Italy, Sites in Italy, Italy; Not yet recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111

Sites in South Korea, South Korea, Korea, Republic of; Not yet recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111

Sites in Lithuania, Lithuania, Lithuania; Not yet recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111

Sites in Poland, Poland, Poland; Not yet recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111

Sites in Russia, Russia, Russian Federation; Not yet recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111

Sites in South Africa, South Africa, South Africa; Not yet recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111

Sites in Sweden, Sites in Sweden 00000, Sweden; Not yet recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111

Sites in Switzerland, Sites in Switzerland, Switzerland; Not yet recruiting
Phone: 41 61 324 1111

Sites in Turkey, Turkey, Turkey; Not yet recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111

Sites in UK, Sites in UK, United Kingdom; Not yet recruiting
Novartis Pharma, Phone: 41 61 324 1111

Sites in USA, East Hanover, New Jersey 07936, United States; Recruiting
Novartis Pharmaceuticals, Phone: 862-778-8300

Starting date: January 2007
Ending date: January 2009
Last updated: June 13, 2008