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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00433836
First received: February 8, 2007
Last updated: April 19, 2011
Last verified: April 2011
  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 3

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: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Mean sitting systolic blood pressure (MSSBP) change after 12 weeks of treatment measured by office blood pressure measurement.


Secondary Outcome Measures:
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from baseline in mean sitting diastolic blood pressure (MSDBP) after 12 weeks of treatment as measured by office blood pressure.

  • Decrease in MSSBP to < 95th Percentile for Age, Gender and Height [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
    The percentage of children whose MSSBP decreased to <95th percentile for age, gender, and height on valsartan vs. enalapril monotherapy at week 12.

  • Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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.


Enrollment: 300
Study Start Date: January 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valsartan 80 mg Drug: Valsartan
Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Experimental: Valsartan 160 mg Drug: Valsartan
Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Experimental: Valsartan 320 mg Drug: Valsartan
Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Active Comparator: Enalapril 10 mg Drug: Enalapril
Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Active Comparator: Enalapril 20 mg Drug: Enalapril
Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Active Comparator: Enalapril 40 mg Drug: Enalapril
Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
Sites in USA
East Hanover, New Jersey, United States, 07936
Belgium
Sites in Belgium
Sites in Belgium, Belgium
France
Sites in France
Sites in France, France
Germany
Sites in Germany
Sites in Germany, Germany
Hungary
Sites in Hungary
Hungary, Hungary
India
Sites in India
Sites in India, India
Italy
Sites in Italy
Sites in Italy, Italy
Poland
Sites in Poland
Poland, Poland
Slovakia
Sites in Slovakia
Slovakia, Slovakia
Sweden
Sites in Sweden
Sites in Sweden, Sweden, 00000
Turkey
Sites in Turkey
Turkey, Turkey
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00433836     History of Changes
Other Study ID Numbers: CVAL489K2302
Study First Received: February 8, 2007
Results First Received: December 8, 2010
Last Updated: April 19, 2011
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
Poland: The Office for Registration of Medicinal Products
Poland: Medical Devices and Biocidal Products
Sweden: Läkemedelsverket Medical Products Agency
Brazil: National Health Surveillance Agency
India: Central Drug Standard Control Organisation
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 August 21, 2014