| Trial ID: | L1764 |
| Source ID: | NCT00446511
|
| Associated Drug: |
Valsartan
|
| Title: |
Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00446511/results
|
| Conditions: |
Hypertension
|
| Interventions: |
DRUG: Valsartan|DRUG: Enalapril|DRUG: placebo matched to enalapril|DRUG: placebo matched to valsartan
|
| Outcome Measures: |
Primary: Number of Patients With Adverse Events, Start of extension (week 13) to end of study (Week 26 in non-CKD patients and Week 50 in CKD patients) | Secondary: Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26, 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., Core Baseline (Week 0) to Week 26|Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26, 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., Week 26|Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20, 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., Core Baseline (Week 0) to Week 20|Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26, 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., Core Baseline (Week 0) to Week 26
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE3
|
| Enrollment: |
250
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-06
|
| Completion Date: |
2009-06
|
| Results First Posted: |
2011-06-06
|
| Last Update Posted: |
2011-07-12
|
| Locations: |
Sites in USA, East Hanover, New Jersey, 07936, United States|Sites in Belgium, Belgium, Belgium|Sites in France, France, France|Sites in Germany, Germany, Germany|Sites in Hungary, Hungary, Hungary|Sites in India, India, India|Sites in Italy, Italy, Italy|Sites in Poland, Poland, Poland|Sites in Turkey, Turkey, Turkey
|
| URL: |
https://clinicaltrials.gov/show/NCT00446511
|
