Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure

A Multicenter, Randomized, Double-blind, Parallel-group, Evaluation of 12 Weeks of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children 6 to 17 Years of Age With Hypertension

The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender and height).

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Valsartan; Drug: Enalapril

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Sites in Belgium, Belgium
    • Sites in Belgium
• France
  • Sites in France, France
    • Sites in France
• Germany
  • Sites in Germany, Germany
    • Sites in germany
• Hungary
  • Hungary, Hungary
    • Sites in Hungary
• India
  • Sites in India, India
    • Sites in India
• Italy
  • Sites in Italy, Italy
    • Sites in Italy
• Poland
  • Poland, Poland
    • Sites in Poland
• Slovakia
  • Slovakia, Slovakia
    • Sites in Slovakia
• Sweden
  • Sites in Sweden, Sweden, 00000
    • sites in Sweden
• Turkey
  • Turkey, Turkey
    • Sites in Turkey
• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Sites in USA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, ages 6-17, with a documented history of hypertension
• Must be able to swallow a pill
• Must be ≥ 18 kg or ≤160 kg
• MSSBP (mean of 3 measurements) must be ≥ 95th percentile, for age, gender and height, at Visit 2 (randomization), by office blood pressure measurement
• Patients who are eligible and able to participate in the study and whose parent(s)/guardian(s) consent in writing (written informed consent) to their doing so after the purpose and nature of the investigation has been clearly explained to them. (An assent will be required for some patients depending upon their age and local requirements regarding assents)

Exclusion Criteria:

• Renal artery stenosis
• Current diagnosis of heart failure (NYHA Class II-IV).
• MSSBP ≥ 25% above the 95th percentile
• 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.
• 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.

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Valsartan 320 mg	Drug: Valsartan; Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Experimental: Valsartan 80 mg	Drug: Valsartan; Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Experimental: Valsartan 160 mg	Drug: Valsartan; Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Active Comparator: Enalapril 10 mg	Drug: Enalapril; Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Active Comparator: Enalapril 20 mg	Drug: Enalapril; Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Active Comparator: Enalapril 40 mg	Drug: Enalapril; Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)	Mean sitting systolic blood pressure (MSSBP) change after 12 weeks of treatment measured by office blood pressure measurement.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)	The change from baseline in mean sitting diastolic blood pressure (MSDBP) after 12 weeks of treatment as measured by office blood pressure.	Baseline and Week 12
Decrease in MSSBP to < 95th Percentile for Age, Gender and Height	The percentage of children whose MSSBP decreased to <95th percentile for age, gender, and height on valsartan vs. enalapril monotherapy at week 12.	at week 12
Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients	The effect of valsartan and enalapril between baseline and visit 6 on 24-hour mean ambulatory systolic and diastolic blood pressure (ASBP, ADBP) in a subset of patients.	Baseline and Week 8

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: February 8, 2007
• First Submitted That Met QC Criteria: February 9, 2007
• First Posted (Estimate): February 12, 2007

Study Record Updates

• Last Update Posted (Estimate): May 19, 2011
• Last Update Submitted That Met QC Criteria: April 19, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: pediatrics; Hypertension; Children; enalapril; High Blood Pressure; Valsartan
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Valsartan; Enalapril
• Other Study ID Numbers: CVAL489K2302