Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure
NCT ID: NCT00433836
Last Updated: 2011-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2007-01-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Valsartan 80 mg
Valsartan
Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Valsartan 160 mg
Valsartan
Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Valsartan 320 mg
Valsartan
Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Enalapril 10 mg
Enalapril
Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Enalapril 20 mg
Enalapril
Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Enalapril 40 mg
Enalapril
Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Interventions
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Valsartan
Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Enalapril
Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
17 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Sites in USA
East Hanover, New Jersey, United States
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, , Sweden
Sites in Turkey
Turkey, , Turkey (Türkiye)
Countries
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Other Identifiers
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CVAL489K2302
Identifier Type: -
Identifier Source: org_study_id
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