Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Valsartan; Enalapril; placebo matched to enalapril; placebo matched to valsartan
Intervention description: Valsartan (80, 160, and 320 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.; Enalapril (10, 20, and 40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.; Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food.; placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
Intervention MeSH terms: Valsartan; Enalapril; Enalaprilat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 250.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: children; pediatrics; high blood pressure; hypertension; valsartan; enalapril

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 children with hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.