Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension
Completed · Phase 3 · Has a placebo group
Conditions studied: Hypertension
In brief
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 children with hypertension.
Key facts
- Study ID
- NCT00446511
- Run by
- Novartis Pharmaceuticals
- People needed
- 250
- Starts
- 2007-06-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2011-07-12
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Sites in USA — East Hanover, New Jersey, United States
- Sites in Belgium — Belgium, Belgium
- Sites in France — France, France
- Sites in Germany — Germany, Germany
- Sites in Hungary — Hungary, Hungary
- Sites in India — India, India
- Sites in Italy — Italy, Italy
- Sites in Poland — Poland, Poland
- Sites in Turkey — Turkey, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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