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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433836
• Other study ID #: CVAL489K2302
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2007
• Last updated: April 19, 2011
• Start date: January 2007
• Est. completion date: February 2009

Study information

• Verified date: April 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Public Service, Health, Food Chain Safety & EnvironmentCzech Republic: State Institute for Drug ControlFrance: Agence Francaise de Sécurite Sanitair des produits de santéGermany: BfArMHungary: National Institute of PharmacyItaly: Italian Medicines AgencyPoland: The Office for Registration of Medicinal ProductsPoland: Medical Devices and Biocidal ProductsSweden: Läkemedelsverket Medical Products AgencyBrazil: National Health Surveillance AgencyIndia: Central Drug Standard Control OrganisationTurkey: Turkey Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Valsartan
Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
• Enalapril
Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.

Locations

Country	Name	City	State
Belgium	Sites in Belgium	Sites in Belgium
France	Sites in France	Sites in France
Germany	Sites in Germany	Sites in Germany
Hungary	Sites in Hungary	Hungary
India	Sites in India	Sites in India
Italy	Sites in Italy	Sites in Italy
Poland	Sites in Poland	Poland
Slovakia	Sites in Slovakia	Slovakia
Sweden	Sites in Sweden	Sites in Sweden
Turkey	Sites in Turkey	Turkey
United States	Sites in USA	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No