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Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pediatric Hypertension With or Without CKD

Intervention: VAL489 (Drug); VAL489 matching placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Overall contact:
Novartis Pharmaceuticals, Phone: 1-888-669-6682

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline (Week 0) in mean systolic blood pressure (MSBP) at Week 6 endpoint

Secondary outcome:

Change from baseline in mean diastolic blood pressure (MDBP) at Week 6 and end of study (26 weeks)

Percentage of patients achieving MSBP < 90th percentile for age, gender and height at Week 6 endpoint and end of study (26 weeks)

Number of patients with Urine Albumin Creatinine Ratio (UACR) response at Week 6 endpoint and end of study (26 weeks)

Number of patients with adverse events, serious adverse events and death

Eligibility

Minimum age: 1 Year. Maximum age: 5 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Novartis Pharmaceuticals, Phone: 1-888-669-6682

Novartis Investigative Site, Antwerpen 2020, Belgium; Recruiting

Novartis Investigative Site, Gent 9000, Belgium; Not yet recruiting

Novartis Investigative Site, Laeken 1020, Belgium; Recruiting

Novartis Investigative Site, Liege 4000, Belgium; Recruiting

Novartis Investigative Site, Campinas 13087-567, Brazil; Recruiting

Novartis Investigative Site, Caxias do Sul 95070-561, Brazil; Not yet recruiting

Novartis Investigative Site, Porto Alegre 90020-090, Brazil; Not yet recruiting

Novartis Investigative Site, Porto Alegre 90610-000, Brazil; Not yet recruiting

Novartis Investigative Site, Porto Alegre 91350-200, Brazil; Not yet recruiting

Novartis Investigative Site, Sao Paulo 04524-030, Brazil; Not yet recruiting

Novartis Investigative Site, Lille 59000, France; Not yet recruiting

Novartis Investigative Site, Montpellier 34059, France; Not yet recruiting

Novartis Investigative Site, Paris Cedex 19 75935, France; Not yet recruiting

Novartis Investigative Site, Toulouse 31059, France; Not yet recruiting

Novartis Investigative Site, Bochum 44791, Germany; Not yet recruiting

Novartis Investigative Site, Bonn 53113, Germany; Not yet recruiting

Novartis Investigative Site, Dortmund 44137, Germany; Not yet recruiting

Novartis Investigative Site, Göttingen D-37075, Germany; Not yet recruiting

Novartis Investigative Site, Marburg 35039, Germany; Recruiting

Novartis Investigative Site, Guatemala City 01010, Guatemala; Recruiting

Novartis Investigative Site, Guatemala 01001, Guatemala; Not yet recruiting

Novartis Investigative Site, Guatemala 1010, Guatemala; Recruiting

Novartis Investigative Site, Quetzaltenango 9001, Guatemala; Not yet recruiting

Novartis Investigative Site, Budapest H-1083, Hungary; Not yet recruiting

Novartis Investigative Site, Budapest H-1096, Hungary; Not yet recruiting

Novartis Investigative Site, Debrecen 4032, Hungary; Not yet recruiting

Novartis Investigative Site, Pecs 7623, Hungary; Not yet recruiting

Novartis Investigative Site, Szeged 6725, Hungary; Recruiting

Novartis Investigative Site, Veszprem H-8200, Hungary; Not yet recruiting

Novartis Investigative Site, Palermo 90134, Italy; Not yet recruiting

Novartis Investigative Site, Vinius 08406, Lithuania; Not yet recruiting

Novartis Investigative Site, Bialystok 15-274, Poland; Recruiting

Novartis Investigative Site, Gdansk 80-952, Poland; Recruiting

Novartis Investigative Site, Krakow 30-663, Poland; Recruiting

Novartis Investigative Site, Lodz 93-338, Poland; Not yet recruiting

Novartis Investigative Site, Lublin 20-093, Poland; Recruiting

Novartis Investigative Site, Poznan 61-825, Poland; Recruiting

Novartis Investigative Site, Szczecin 71-252, Poland; Recruiting

Novartis Investigative Site, Warsaw 04-730, Poland; Not yet recruiting

Novartis Investigative Site, Warszawa 04-154, Poland; Recruiting

Novartis Investigative Site, Madrid 28046, Spain; Not yet recruiting

Novartis Investigative Site, Bari, BA 70124, Italy; Not yet recruiting

Novartis Investigative Site, Bologna, BO 40138, Italy; Recruiting

Novartis Investigative Site, Firenze, FI 50132, Italy; Not yet recruiting

Novartis Investigative Site, San Donato Milanese, MI 20097, Italy; Recruiting

Novartis Investigative Site, Padova, PD 35128, Italy; Not yet recruiting

Novartis Investigative Site, Curitibia, Parana 80250-060, Brazil; Recruiting

Novartis Investigative Site, Roma, RM 00165, Italy; Not yet recruiting

Novartis Investigative Site, Torino, TO 10126, Italy; Not yet recruiting

Novartis Investigative Site, Houston, Texas 77030, United States; Not yet recruiting

Additional Information

Starting date: October 2012
Last updated: August 11, 2015

Page last updated: August 20, 2015

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