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

Hypertension Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446511
• Other study ID #: CVAL489K2302E1
• Status: Completed
• Phase: Phase 3
• First received: March 9, 2007
• Last updated: June 30, 2011
• Start date: June 2007
• Est. completion date: June 2009

Study information

• Verified date: June 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 & EnvironmentFrance : Agence Francaise de Sécurite Sanitair des produits de santéGermany : Federal Institute for Drugs and Medical Devices (BfArM)Hungary: National Institute of PharmacyItaly : Italian Medicines AgencyPoland : The Office for Registration of Medicinal Products,Medical Devices and Biocidal ProductsIndia : Central Drug Standard Control OrganizationTurkey : Turkey Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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.

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

Locations

Country	Name	City	State
Belgium	Sites in Belgium	Belgium
France	Sites in France	France
Germany	Sites in Germany	Germany
Hungary	Sites in Hungary	Hungary
India	Sites in India	India
Italy	Sites in Italy	Italy
Poland	Sites in Poland	Poland
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,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Adverse Events		Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients)	Yes
Secondary	Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26	After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure.	Core Baseline (Week 0) to Week 26	No
Secondary	Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26	Systolic and diastolic blood pressure (BP) control was defined as msSBP and msDBP < 95th percentile for gender, age, and height. After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit.	Week 26	No
Secondary	Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20	24-hour ambulatory blood pressure monitoring (ABPM) was conducted once during the extension in a subset of patients at selected centers. For all patients who completed a qualifying ABPM at baseline, an ABPM was to be performed at Week 20. The ABPM monitor was placed on the non-dominant arm.	Core Baseline (Week 0) to Week 20	No
Secondary	Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26	After the patient had been sitting for 5 minutes, with the back supported and both feet placed on the floor, systolic and diastolic blood pressures were measured 3 times using a calibrated standard sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. A negative number indicates lowered blood pressure.	Core Baseline (Week 0) to Week 26	No