Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Valsartan (Drug); Enalapril (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Overall contact:
Novartis Pharmaceuticals, Phone: 862-778-8300
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).
Clinical Details
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 (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Reduction of mean sitting systolic blood pressure (MSSBP)
Secondary outcome: Reduction of mean sitting diastolic blood pressure (MSDBP)Decrease in MSSBP to < 95th percentile for age, gender and height Change in mean ambulatory systolic blood pressure and mean ambulatory diastolic blood pressure over 24 hours in subset of patients Safety and tolerability of valsartan compared to enalapril
Eligibility
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
Locations and Contacts
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
Additional Information
Starting date: February 2007
Ending date: February 2009
Last updated: December 16, 2008
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