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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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CKD patients: Valsartan+enalapril

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

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

Intervention Type DRUG

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.

CKD patients: Enalapril

Group Type ACTIVE_COMPARATOR

Enalapril

Intervention Type DRUG

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 valsartan

Intervention Type DRUG

placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food.

Non-CKD patients: Valsartan

Group Type EXPERIMENTAL

Valsartan

Intervention Type DRUG

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.

placebo matched to enalapril

Intervention Type DRUG

Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food.

Non-CKD patients: Enalapril

Group Type ACTIVE_COMPARATOR

Enalapril

Intervention Type DRUG

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 valsartan

Intervention Type DRUG

placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food.

Interventions

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Valsartan

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.

Intervention Type DRUG

Enalapril

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.

Intervention Type DRUG

placebo matched to enalapril

Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food.

Intervention Type DRUG

placebo matched to valsartan

placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No