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

February 8, 2007
April 19, 2011
January 2007
February 2009   (final data collection date for primary outcome measure)
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.
Reduction of mean sitting systolic blood pressure (MSSBP) at Week 12 from baseline
Complete list of historical versions of study NCT00433836 on ClinicalTrials.gov Archive Site
  • 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.
  • Reduction of mean sitting diastolic blood pressure (MSDBP) at Week 12 from baseline
  • Decrease in MSSBP to < 95th percentile for age, gender and height at Week 12
  • Change in mean ambulatory systolic blood pressure and mean ambulatory diastolic blood pressure over 24 hours in subset of patients, Week 12 compared to baseline
  • Safety and tolerability of valsartan compared to enalapril
Not Provided
Not Provided
 
Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: Valsartan
    Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
  • Drug: Enalapril
    Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
  • Experimental: Valsartan 80 mg
    Intervention: Drug: Valsartan
  • Experimental: Valsartan 160 mg
    Intervention: Drug: Valsartan
  • Experimental: Valsartan 320 mg
    Intervention: Drug: Valsartan
  • Active Comparator: Enalapril 10 mg
    Intervention: Drug: Enalapril
  • Active Comparator: Enalapril 20 mg
    Intervention: Drug: Enalapril
  • Active Comparator: Enalapril 40 mg
    Intervention: Drug: Enalapril
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
February 2009
February 2009   (final data collection date for primary outcome measure)

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

Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Hungary,   India,   Italy,   Poland,   Slovakia,   Sweden,   Turkey,   United States
 
NCT00433836
CVAL489K2302
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP