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 Chronic kidney disease (CKD). In addition it will evaluate proteinuria reduction, renopreservation, and tolerability of valsartan and enalapril combination vs. enalapril monotherapy alone in patients with chronic kidney disease.

Condition	Intervention	Phase
Hypertension	Drug: Valsartan, enalapril	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

Long-term safety and tolerability of valsartan and enalapril [ Time Frame: at every visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percentage of non-Chronic Kidney Disease (CKD) patients with a Mean sitting Systolic Blood Pressure < 95th percentile for gender, age and height [ Time Frame: baseline to week 26 ] [ Designated as safety issue: No ]
Mean seated systolic blood pressure reduction in non-CKD patients [ Time Frame: from baseline to week 26. ] [ Designated as safety issue: No ]
Mean ambulatory blood pressure reduction as measured by 24 hour ABPM. [ Time Frame: from baseline to week 26 ] [ Designated as safety issue: No ]
Percentage of CKD patients treated achieving urine protein/creatinine ratio (UPCR) reduction by ≥ 25% [ Time Frame: from week 12 to week 26 ] [ Designated as safety issue: No ]
Percentage of CKD patients who have urine protein/creatinine ratio (UPCR) reduced by ≥ 50% [ Time Frame: from baseline to week 26 ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	June 2007
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

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.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

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

Show 25 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CVAL489K2302E1
Study First Received:	March 9, 2007
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00446511 History of Changes
Health Authority:	United States: Food and Drug Administration; Belgium : Federal Public Service, Health, Food Chain Safety & Environment; Czech Republic: State Institute for Drug Control; 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; Lithuania : State Medicines Control Agency; Poland : The Office for Registration of Medicinal Products,Medical Devices and Biocidal Products; Sweden : Läkemedelsverket Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Brazil: National Health Surveillance Agency; India : Central Drug Standard Control Organization; South Africa : Department of Health Affairs; Switzerland : Swissmedic - Agency for Therapeutic Products; Turkey : Turkey Ministry of Health

Keywords provided by Novartis:

Children
pediatrics
High Blood Pressure

Hypertension
Valsartan
enalapril

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

Enalapril
Enalaprilat
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009