Phase 3
Completed N=150
Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age
Source: ClinicalTrials.gov NCT01365481 ↗Enrolled (actual)
150
Serious AEs
10.0%
Results posted
Apr 2016
Primary outcomePrimary: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF) — -13.3; -15.5 millimeter(s) of mercury (mmHg)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to assess the long-term safety and tolerability profile of valsartan and valsartan-based treatments in children with hypertension, with or without chronic kidney disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF) |
-13.3; -15.5 | — |
| PRIMARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (MsDBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF) |
-10.3; -10.8 | — |
| SECONDARY Number of Participants With MSSBP, MSDBP and (MSSBP and MSDBP Combined) < 95th Percentile for Gender, Age, and Height |
23; 90; 20; 47; 22; 88 | — |
| SECONDARY Percentage of Chronic Kidney Disease (CKD) Patients Who Had >=50% Reduction in Urine Albumin/Creatinine Ratio (UACR) From Baseline to End Point |
50.0; 41.9 | — |
| SECONDARY Percentage of Chronic Kidney Disease (CKD) Patients Who Had Estimated Glomerular Filtration Rate (eGFR) Decrease > 25 % From Baselinefrom Baseline to End Point |
30.4; 27.5 | — |
Eligibility Criteria
Inclusion Criteria
- Documented diagnosis of hypertension
- able to swallow a tablet
- body weight ≥18 kg and ≤160 kg at baseline
- MSSBP must be ≥ 95th percentile and ≤25% above the 95th percentile for age, gender and height.
Exclusion Criteria
- Any clinically significant physical abnormalities or clinically relevant abnormal laboratory values (other than those relating to renal function) obtained at the screening visit. Including the following:
- AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range. Patients known to have active or chronic hepatitis were excluded.
- Total bilirubin >2 times the upper limit of the reference range
- Estimated GFR 5.3 mmol/L
- Hemoglobin 3g/day, and non-selective NSAIDs, Antidepressant drugs in the class of Monoamine oxidase (MAO) inhibitors (e.g. phenelzine), Chronic use of stimulant therapy for Attention deficit disorder/attention deficit hyperactivity disorder (ADD/ADHD) -Patients who demonstrate clinically significant ECG abnormalities such as concurrent potentially life threatening arrhythmia or symptomatic arrhythmia and patients with second or third degree heart block without a pacemaker.
- Coarctation of the aorta with a gradient of >=30 mmHg
- Previous solid organ transplantation except renal transplantation.
- Patients known to be positive for the human immunodeficiency virus (HIV)
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drug
- Known or suspected contraindications to the study drug, including severe hepatic impairment, biliary cirrhosis, cholestasis and history of allergy to ARBs and/or angiotensin-converting enzymes (ACE) and/or Direct Renin Inhibitors (DRIs)
- History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- History or evidence of drug or alcohol abuse within the last 12 months.
- Female patients of child-bearing potential, defined as all female patients physiologically capable of becoming pregnant, unless they are willing to use highly effective contraception during the study
- Pregnant or nursing (lactating) female patients
- Participation in any investigational drug study within 30 days prior to screening or within 5 elimination half-lives of the study drug prior to screening, or whichever is longer.
- History of hypersensitivity to the study drug or to drugs of similar chemical classes.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01365481). 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.