Phase 3
Completed N=250
Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension
Source: ClinicalTrials.gov NCT00446511 ↗Enrolled (actual)
250
Serious AEs
4.0%
Results posted
Jun 2011
Primary outcomePrimary: Number of Patients With Adverse Events — 16; 11; 51; 53 Participants
Summary
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 hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events |
16; 11; 51; 53 | — |
| SECONDARY Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 26 |
-20.4; -11.7; -7.5; -7.2 | — |
| SECONDARY Percentage of Non-CKD Patients Achieving Systolic and Diastolic BP Control at Week 26 |
66.0; 63.0; 95.1; 91.7 | — |
| SECONDARY Change From Baseline in Post-dosing 24-hour Mean Systolic and Diastolic Ambulatory Blood Pressure at Week 20 |
-23.3; -0.3; -11.5; -4.1; -17.8; 2.9 | — |
| SECONDARY Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 26 |
-23.6; -18.2; -11.6; -10.2 | — |
Eligibility 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.
- Patients who experienced any adverse events considered serious and drug related in protocol CVAL489K2302.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT00446511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.