Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: placebo matched to valsartan; Drug: Enalapril; Drug: Valsartan; Drug: placebo matched to enalapril

Study type: Interventional

Funder types: Industry

Identifiers

NCT00446511

CVAL489K2302E1

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 4 patient groups

CKD patients: Valsartan+enalapril

Experimental group

Treatment:

Drug: Valsartan

Drug: Enalapril

CKD patients: Enalapril

Active Comparator group

Treatment:

Drug: placebo matched to valsartan

Drug: Enalapril

Non-CKD patients: Valsartan

Experimental group

Treatment:

Drug: Valsartan

Drug: placebo matched to enalapril

Non-CKD patients: Enalapril

Active Comparator group

Treatment:

Drug: placebo matched to valsartan

Drug: Enalapril