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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00446511
• Date of registration: 09/03/2007
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension
• Scientific title: An Extension to Study Protocol CVAL489K2302 to Evaluate the Long Term Safety, Tolerability and Efficacy of Valsartan in Children 6 to 17 Years of Age With Hypertension, Versus Enalapril Treatment for 14 Weeks, or Combined With Enalapril Versus Enalapril for 66 Weeks in Chronic Kidney Disease Patients.
• Date of first enrolment: June 2007
• Target sample size: 250
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00446511
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Belgium, France, Germany, Hungary, India, Italy, Poland, Turkey, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Drug: Enalapril

Drug: placebo matched to valsartan

Drug: placebo matched to enalapril

Drug: Valsartan

Primary Outcome(s)

Number of Patients With Adverse Events [Time Frame: Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)]

Secondary Outcome(s)

Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26 [Time Frame: Week 26]

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26 [Time Frame: Core Baseline (Week 0) to Week 26]

Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20 [Time Frame: Core Baseline (Week 0) to Week 20]

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26 [Time Frame: Core Baseline (Week 0) to Week 26]

Secondary ID(s)

CVAL489K2302E1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/06/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00446511