Status:
COMPLETED
Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypertension
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in chil...
Eligibility Criteria
Inclusion
- Successful completion of 12 weeks of double-blind treatment in core protocol CVAL489K2302.
- Patients participating in study CVAL489K2302 who may have discontinued prematurely due to uncontrolled hypertension defined as MSSBP \> 20%, but \< 25% above the 95th percentile for age, gender, and height after visit 5, qualifies a patient for entry into this extension study.
Exclusion
- Renal artery stenosis.
- Current diagnosis of heart failure (NYHA Class II-IV).
- 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 and AV block controlled with a pacemaker.
- 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.
- Patients who experienced any adverse events considered serious and drug related in protocol CVAL489K2302.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00446511
Start Date
June 1 2007
End Date
June 1 2009
Last Update
July 12 2011
Active Locations (9)
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1
Sites in USA
East Hanover, New Jersey, United States, 07936
2
Sites in Belgium
Belgium, Belgium
3
Sites in France
France, France
4
Sites in Germany
Germany, Germany