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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Valsartan; Drug: Enalapril

• Registration Number: NCT00433836
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-02-08
• Study First Submitted QC: 2007-02-09
• Study First Posted: 2007-02-12
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2010-12-08
• Status Verified: 2011-04
• Results First Submitted QC: 2011-04-19
• Last Update Submitted: 2011-04-19
• Results First Posted: 2011-05-19
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valsartan 160 mg	Valsartan	-
Enalapril 20 mg	Enalapril	-
Enalapril 40 mg	Enalapril	-
Valsartan 80 mg	Valsartan	-
Valsartan 320 mg	Valsartan	-
Enalapril 10 mg	Enalapril	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)	Baseline and Week 12	The change from baseline in mean sitting diastolic blood pressure (MSDBP) after 12 weeks of treatment as measured by office blood pressure.
Decrease in MSSBP to < 95th Percentile for Age, Gender and Height	at week 12	The percentage of children whose MSSBP decreased to \<95th percentile for age, gender, and height on valsartan vs. enalapril monotherapy 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	Baseline and Week 8	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.

Trial Locations

Locations (11)

Sites in Italy; 🇮🇹 Sites in Italy, Italy

Sites in France; 🇫🇷 Sites in France, France

Sites in Sweden; 🇸🇪 Sites in Sweden, Sweden

Sites in Germany; 🇩🇪 Sites in Germany, Germany

Sites in Poland; 🇵🇱 Poland, Poland

Sites in USA; 🇺🇸 East Hanover, New Jersey, United States

Sites in India; 🇮🇳 Sites in India, India

Sites in Slovakia; 🇸🇰 Slovakia, Slovakia

Sites in Belgium; 🇧🇪 Sites in Belgium, Belgium

Sites in Turkey; 🇹🇷 Turkey, Turkey

Sites in Hungary; 🇭🇺 Hungary, Hungary