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

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00446511

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Valsartan Drug: Enalapril Drug: placebo matched to enalapril Drug: placebo matched to valsartan	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Enalapril Enalapril maleate Enalaprilat Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26 [ Time Frame: Core Baseline (Week 0) to Week 26 ] [ Designated as safety issue: No ]
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.
Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
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.
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26 [ Time Frame: Core Baseline (Week 0) to Week 26 ] [ Designated as safety issue: No ]
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.

Enrollment:	250
Study Start Date:	June 2007
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CKD patients: Valsartan+enalapril	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. Drug: 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.
Active Comparator: CKD patients: Enalapril	Drug: 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. Drug: 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.
Experimental: Non-CKD patients: Valsartan	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. Drug: 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.
Active Comparator: Non-CKD patients: Enalapril	Drug: 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. Drug: 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.

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446511

Locations

United States, New Jersey
Sites in USA
East Hanover, New Jersey, United States, 07936
Belgium
Sites in Belgium
Belgium, Belgium
France
Sites in France
France, France
Germany
Sites in Germany
Germany, Germany
Hungary
Sites in Hungary
Hungary, Hungary
India
Sites in India
India, India
Italy
Sites in Italy
Italy, Italy
Poland
Sites in Poland
Poland, Poland
Turkey
Sites in Turkey
Turkey, Turkey

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00446511 History of Changes
Other Study ID Numbers:	CVAL489K2302E1
Study First Received:	March 9, 2007
Results First Received:	January 11, 2011
Last Updated:	June 30, 2011
Health Authority:	United States: Food and Drug Administration; Belgium : Federal Public Service, Health, Food Chain Safety & Environment; France : Agence Francaise de Sécurite Sanitair des produits de santé; Germany : Federal Institute for Drugs and Medical Devices (BfArM); Hungary: National Institute of Pharmacy; Italy : Italian Medicines Agency; Poland : The Office for Registration of Medicinal Products,Medical Devices and Biocidal Products; India : Central Drug Standard Control Organization; Turkey : Turkey Ministry of Health

Keywords provided by Novartis:

children
pediatrics
high blood pressure

hypertension
valsartan
enalapril

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Enalapril
Enalaprilat
Valsartan
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 12, 2012