Pediatric Hypertension With or Without CKD Clinical Trial
Official title:
A 6 Week, Randomized, Multicenter, Double-blind, Double-dummy Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 1-5 Years Old With Hypertension, With or Without Chronic Kidney Disease, Followed by a 20 Week Open-label Titration Phase
| Verified date | August 2017 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To assess efficacy, safety and tolerability of valsartan when comparing two doses of valsartan in reducing and controlling blood pressure in children with hypertension with or without CKD.
| Status | Completed |
| Enrollment | 127 |
| Est. completion date | January 24, 2017 |
| Est. primary completion date | January 24, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 5 Years |
| Eligibility |
Inclusion Criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria: Have the ability to provide written informed consent; Have at baseline , a documented diagnosis of hypertension (as defined in the National High Blood Pressure Education Program 2004); MSBP (mean of 3 measurements) must be =95th percentile, and =25% above the 95th percentile, for age, gender and height, at baseline; CKD patients must be defined as any of the following criteria: Kidney damage for =3 months, as defined by structural or functional abnormalities of the kidney, with or without decreased GFR, manifested by one or more of the following features: Abnormalities in the composition of urine, Abnormalities in imaging tests, Abnormalities on kidney biopsy, Estimated eGFR <60 mL/min/1.73m2 for =3 months, with or without the other signs of kidney damage described above; Able to swallow the valsartan solution; Body weight must be =8 kg and =40 kg at baseline; Must be able to safely washout from other antihypertensive therapy (if applicable) Exclusion criteria AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range; Estimated Glomerular Filtration Rate [eGFR] <30 mL/min/1.73m² (calculated using Modified Schwartz Formula); Serum potassium >5.3 mmol/L; Uncontrolled diabetes mellitus, as defined by the investigator; Unilateral, bilateral and graft renal artery stenosis; Current diagnosis of heart failure (NYHA Class II-IV); Patients taking any of the following concomitant medications following screening: RAAS blockers other than study drug, Lithium, Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels; Non-steroidal anti-inflammatory drugs (NSAIDS), including selective COX-2 inhibitors, acetylsalicylic acid >3g/day, and non-selective NSAIDs (paracetamol/acetaminophen is permitted); Antidepressant drugs in the class of MAO inhibitors (e.g. phenelzine); Chronic use of stimulant therapy for ADD/ADHD; patients who have coarctation of the aorta with a gradient of =30 mmHg; Previous solid organ transplantation except renal transplantation. Renal transplant must have occurred at least 1 year prior to enrollment; Patient must be on stable doses of immunosuppressive therapy and deemed clinically stable by the investigator; Patients known to be positive for the human immunodeficiency virus (HIV) Other protocol defined inclusion/exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Novartis Investigative Site | Antwerpen | |
| Belgium | Novartis Investigative Site | Liege | |
| Brazil | Novartis Investigative Site | Campinas | |
| Brazil | Novartis Investigative Site | Caxias do Sul | |
| Brazil | Novartis Investigative Site | Curitibia | Parana |
| Brazil | Novartis Investigative Site | Porto Alegre | |
| France | Novartis Investigative Site | Montpellier | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Marburg | |
| Guatemala | Novartis Investigative Site | Guatemala | |
| Guatemala | Novartis Investigative Site | Guatemala | |
| Guatemala | Novartis Investigative Site | Guatemala City | |
| Hungary | Novartis Investigative Site | Budapest | |
| Hungary | Novartis Investigative Site | Budapest | |
| Hungary | Novartis Investigative Site | Szeged | |
| Italy | Novartis Investigative Site | Bologna | BO |
| Italy | Novartis Investigative Site | Palermo | |
| Italy | Novartis Investigative Site | San Donato Milanese | MI |
| Lithuania | Novartis Investigative Site | Vinius | |
| Poland | Novartis Investigative Site | Bialystok | |
| Poland | Novartis Investigative Site | Gdansk | |
| Poland | Novartis Investigative Site | Krakow | |
| Poland | Novartis Investigative Site | Lodz | |
| Poland | Novartis Investigative Site | Lublin | |
| Poland | Novartis Investigative Site | Poznan | |
| Poland | Novartis Investigative Site | Szczecin | |
| Poland | Novartis Investigative Site | Warszawa |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Belgium, Brazil, France, Germany, Guatemala, Hungary, Italy, Lithuania, Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Mean Systolic Blood Pressure (MSBP) at Week 6 Endpoint | Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) at Baseline and Week 6 endpoint in Period 1 Double Blind Phase | Baseline, week 6 | |
| Secondary | Change From Baseline in Mean Diastolic Blood Pressure (MDBP) at Week 6 | Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) Baseline and Week 6 endpoint in Period 1 Double Blind Phase | Baseline, Week 6 | |
| Secondary | Patients Achieving <90th Percentile for Age, Gender and Height at Week 6 Endpoint in Both MSBP and MDBP | Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) Week 6 | Week 6 | |
| Secondary | CKD Patients Achieving Urine Albumin Creatinine Ratio Percentage Reduction (UACR) >=25% at Week 6 | UACR response is defined as percentage change from baseline in UACR= 25%. UACR [mg/mmol] = urine albumin [mg/L] / urine creatinine [mmol/L] UACR was collected for CKD patients only. The UACR value at a given visit for a patient was to be derived by the median of the three lab values collected for that visit Week 6. | Week 6 weeks |