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Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure
This study is currently recruiting participants.
Verified by Novartis, December 2008
First Received: February 8, 2007   Last Updated: December 16, 2008   History of Changes
Sponsored by: Novartis Pharmaceuticals
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00433836
  Purpose

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).


Condition Intervention Phase
Hypertension
Drug: Valsartan
Drug: Enalapril
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Evaluation of 12 Weeks of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children 6 to 17 Years of Age With Hypertension

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Reduction of mean sitting systolic blood pressure (MSSBP) [ Time Frame: from baseline to week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of mean sitting diastolic blood pressure (MSDBP) [ Time Frame: from baseline to week 12 ] [ Designated as safety issue: No ]
  • Decrease in MSSBP to < 95th percentile for age, gender and height [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Change in mean ambulatory systolic blood pressure and mean ambulatory diastolic blood pressure over 24 hours in subset of patients [ Time Frame: week 12 compared to baseline ] [ Designated as safety issue: No ]
  • Safety and tolerability of valsartan compared to enalapril [ Time Frame: every visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: February 2007
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Valsartan 80 mg: Experimental Drug: Valsartan
Valsartan 160 mg: Experimental Drug: Valsartan
Valsartan 320 mg: Experimental Drug: Valsartan
Enalapril 10 mg: Active Comparator Drug: Enalapril
Enalapril 20 mg: Active Comparator Drug: Enalapril
Enalapril 40 mg: Active Comparator Drug: Enalapril

  Eligibility

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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433836

Contacts
Contact: Novartis Pharmaceuticals 862-778-8300
Contact: Novartis Pharmaceuticals Novartis: 41 61 324 1111

  Show 19 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers: CVAL489K2302
Study First Received: February 8, 2007
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00433836     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: BfArM;   Hungary: National Institute of Pharmacy;   Italy: Italian Medicines Agency;   Lithuania: State Medicines Control Agency;   Poland: The Office for Registration of Medicinal Products;   Poland: Medical Devices and Biocidal Products;   Sweden: Läkemedelsverket Medical Products Agency;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Austrailia: Department of Health & Ageing;   Brazil: National Health Surveillance Agency;   Chile: Instituto de Salud Pública de Chile;   India: Central Drug Standard Control Organisation;   New Zealand: MEDSAFE - New Zealand Medicines and Medical Devices Safety Authority;   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

Study placed in the following topic categories:
Enalapril
Enalaprilat
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Valsartan
Protease Inhibitors
Hypertension

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 July 02, 2009