Trial reportJournal of clinical hypertension (Greenwich, Conn.)2011
Effectiveness and safety of valsartan in children aged 6 to 16 years with hypertension.
Trial report in Journal of clinical hypertension (Greenwich, Conn.), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00171041 (A Double-Blind, Randomized, Multi-Center Study Followed By 12 Months Open-Label Treatment To Evaluate The Dose Response And Safety Of Valsartan In Pediatric Hypertensive Patients), which is not on this map. Cited by 22 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-Blind, Randomized, Multi-Center Study Followed By 12 Months Open-Label Treatment To Evaluate The Dose Response And Safety Of Valsartan In Pediatric Hypertensive Patients
Who cites it
22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 51 citations in OpenAlex.
- Narrative update of clinical trials with antihypertensive drugs in children and adolescents.Frontiers in cardiovascular medicine · 2022Pooled it
- Hypertension in Children and Adolescents: A Position Statement From a Panel of Multidisciplinary Experts Coordinated by the French Society of Hypertension.Frontiers in pediatrics · 2021Pooled it
- Pharmacological interventions for hypertension in children.The Cochrane database of systematic reviews · 2014Pooled it
- Safety and efficacy of azilsartan in paediatric patients with hypertension: a phase 3, single-arm, open-label, prospective study.Clinical and experimental nephrology · 2022Trial
- Long-term safety and tolerability of valsartan in children aged 6 to 17 years with hypertension.Pediatric nephrology (Berlin, Germany) · 2019Trial
- Pharmacokinetics of a Single Dose of Azilsartan in Pediatric Patients: A Phase 3, Open-Label, Multicenter Study.Advances in therapy · 2018Trial
- Effects of combining azilsartan medoxomil with amlodipine in patients with stage 2 hypertension.Blood pressure monitoring · 2014Trial
- The efficacy and safety of valsartan in obese and non-obese pediatric hypertensive patients.Journal of clinical hypertension (Greenwich, Conn.) · 2011Trial
- Precision approaches to paediatric hypertension: linking pathophysiology to therapy.Pediatric nephrology (Berlin, Germany) · 2026Review
- Preparation and evaluation of valsartan orodispersible tablets using PVP-K30 and HPMC E3 solid dispersions by the solvent evaporation method.Research in pharmaceutical sciences · 2025Article
- Clinical guidelines for the diagnosis, evaluation, and management of hypertension for Korean children and adolescents: the Korean Working Group of Pediatric Hypertension.Kidney research and clinical practice · 2025Article
- Extemporaneous Compounding and Physiological Modeling of Amlodipine/Valsartan Suspension.International journal of hypertension · 2021Article
- Antihypertensive agents: a long way to safe drug prescribing in children.Pediatric nephrology (Berlin, Germany) · 2020Review
- Research Gaps in Primary Pediatric Hypertension.Pediatrics · 2019Review
- Recommendations to Enhance Pediatric Cardiovascular Drug Development: Report of a Multi-Stakeholder Think Tank.Journal of the American Heart Association · 2018Article
- Pharmacologic Treatment of Pediatric Hypertension.Current hypertension reports · 2016Review
- Single-dose pharmacokinetics and safety of azilsartan medoxomil in children and adolescents with hypertension as compared to healthy adults.European journal of clinical pharmacology · 2016Article
- Anti-hypertensive drugs in children and adolescents.World journal of cardiology · 2014Review
- Update on the pharmacologic treatment of hypertension in pediatrics.Journal of clinical hypertension (Greenwich, Conn.) · 2012Review
- Valsartan: in children and adolescents with hypertension.Paediatric drugs · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 7 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The effectiveness and safety of valsartan have not been assessed in hypertensive children. Therefore, hypertensive patients aged 6 to 16 years (n=261) were randomized to receive weight-stratified low- (10/20 mg), medium- (40/80 mg), or high-dose (80/160 mg) valsartan for 2 weeks. After 2 weeks, patients were randomized to a 2-week placebo-controlled withdrawal phase. Dose-dependent reductions in sitting systolic blood pressure (SSBP) and sitting diastolic blood pressure (SDBP) were observed after 2 weeks (low dose, -7.9/-4.6 mm Hg; medium dose, -9.6/-5.8 mm Hg; high dose, -11.5/-7.4 mm Hg [P<.0001 for all groups]). During the withdrawal phase, SSBP and SDBP were both lower in the pooled valsartan group than in the pooled placebo group (SSBP, -2.7 mm Hg [P=.0368]; SDBP, -3.0 mm Hg [P=.0047]). Similar efficacy was observed in all subgroups. Valsartan was well tolerated and headache was the most commonly observed adverse event during both the double-blind and 52-week open-label phases.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.