Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Valsartan (Drug); Enalapril (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
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, 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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
Secondary outcome: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)Decrease in MSSBP to < 95th Percentile for Age, Gender and Height Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients
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
Sites in Belgium, Sites in Belgium, Belgium
Sites in France, Sites in France, France
Sites in Germany, Sites in Germany, Germany
Sites in Hungary, Hungary, Hungary
Sites in India, Sites in India, India
Sites in Italy, Sites in Italy, Italy
Sites in Poland, Poland, Poland
Sites in Slovakia, Slovakia, Slovakia
Sites in Sweden, Sites in Sweden 00000, Sweden
Sites in Turkey, Turkey, Turkey
Sites in USA, East Hanover, New Jersey 07936, United States
Additional Information
Starting date: January 2007
Last updated: April 19, 2011
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