--- title: A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension nct_id: NCT00457626 overall_status: COMPLETED phase: PHASE3 sponsor: Novartis Pharmaceuticals study_type: INTERVENTIONAL primary_condition: Hypertension countries: United States, Belgium, Brazil, France, Hungary, India, Italy, Poland, South Africa, Turkey (Türkiye) canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00457626.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00457626" ct_last_update_post_date: 2021-09-05 last_seen_at: "2026-05-12T07:32:54.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension **Official Title:** An Open Label Extension Study to Evaluate Safety, Tolerability, and Efficacy of 18 Weeks of Valsartan Treatment in Children 6 Months-5 Years Old With Hypertension **NCT ID:** [NCT00457626](https://clinicaltrials.gov/study/NCT00457626) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 66 - **Lead Sponsor:** Novartis Pharmaceuticals - **Conditions:** Hypertension - **Start Date:** 2007-04-09 - **Completion Date:** 2009-05-25 - **CT.gov Last Update:** 2021-09-05 ## Brief Summary The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension. ## Eligibility - **Minimum age:** 6 Months - **Maximum age:** 5 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion criteria * Participants who qualified and entered the core study. * Participants who participated in the core study, completed Period 1 and were re-randomized in Period 2 and continued for at least 3 days in Period 2. Exclusion criteria * Participants who did not complete Period 1 of the core study. * Participants who were re-randomized in Period 2 of core study but did not continue for =\> 3 days in Period 2 of the core study. * Participants who experienced any adverse events considered serious or drug related in the core study. * Participants excluded from the core study. ``` ## Arms - **Valsartan Open Label** (EXPERIMENTAL) — Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg, escalated to 2 mg/kg or 4 mg/kg based on mean sitting systolic blood pressure (MSSBP) control after 2 weeks up to 18 weeks. ## Interventions - **Valsartan** (DRUG) — Extemporaneous suspension of valsartan, orally. ## Primary Outcomes - **Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)** _(time frame: Baseline to Week 26)_ — Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sitting systolic blood pressure (SSBP) measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement. - **Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)** _(time frame: Baseline to Week 26)_ — Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three SDBP measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement. - **Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)** _(time frame: Week 8 to Week 26 of Extension Phase)_ — An AE was defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. ## Locations (36) - Novartis Investigative Site, Hackensack, New Jersey, United States - Novartis Investigative Site, Philadelphia, Pennsylvania, United States - Novartis Investigative Site, Norfolk, Virginia, United States - Novartis Investigative Site, Antwerp, Belgium - Novartis Investigative Site, Edegem, Belgium - Novartis Investigative Site, Ghent, Belgium - Novartis Investigative Site, Laken, Belgium - Novartis Investigative Site, Liège, Belgium - Novartis Investigative Site, Goiânia, Goiás, Brazil - Novartis Investigative Site, Curitiba, Paraná, Brazil - Novartis Investigative Site, Recife, Pernambuco, Brazil - Novartis Investigative Site, Marseille, France - Novartis Investigative Site, Paris, France - Novartis Investigative Site, Toulouse, France - Novartis Investigative Site, Budapest, Hungary - Novartis Investigative Site, Szeged, Hungary - Novartis Investigative Site, Hyderabad, Andh Prad, India - Novartis Investigative Site, Mangalore, Karnataka, India - Novartis Investigative Site, Indore, M.P., India - Novartis Investigative Site, Mumbai, Maharashtra, India - Novartis Investigative Site, Chennai, Tamil Nadu, India - Novartis Investigative Site, New Delhi, India - Novartis Investigative Site, Torino, TO, Italy - Novartis Investigative Site, Palermo, Italy - Novartis Investigative Site, Gdansk, Poland - Novartis Investigative Site, Krakow, Poland - Novartis Investigative Site, Lodz, Poland - Novartis Investigative Site, Poznan, Poland - Novartis Investigative Site, Szczecin, Poland - Novartis Investigative Site, Warsaw, Poland - Novartis Investigative Site, Gezina, Gauteng, South Africa - Novartis Investigative Site, Cape Town, South Africa - Novartis Investigative Site, Potchefstroom, South Africa - Novartis Investigative Site, Pretoria, South Africa - Novartis Investigative Site, Ankara, Turkey (Türkiye) - Novartis Investigative Site, Izmir, Turkey (Türkiye) ## Recent Field Changes (last 30 days) - `armsInterventions.interventions` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.novartis investigative site|hackensack|new jersey|united states` — added _(2026-05-12)_ - `locations.novartis investigative site|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ - `locations.novartis investigative site|norfolk|virginia|united states` — added _(2026-05-12)_ - `locations.novartis investigative site|antwerp||belgium` — added _(2026-05-12)_ - `locations.novartis investigative site|edegem||belgium` — added _(2026-05-12)_ - `locations.novartis investigative site|ghent||belgium` — added _(2026-05-12)_ - `locations.novartis investigative site|laken||belgium` — added _(2026-05-12)_ - `locations.novartis investigative site|liège||belgium` — added _(2026-05-12)_ - `locations.novartis investigative site|goiânia|goiás|brazil` — added _(2026-05-12)_ - `locations.novartis investigative site|curitiba|paraná|brazil` — added _(2026-05-12)_ - `locations.novartis investigative site|recife|pernambuco|brazil` — added _(2026-05-12)_ - `locations.novartis investigative site|marseille||france` — added _(2026-05-12)_ - `locations.novartis investigative site|paris||france` — added _(2026-05-12)_ - `locations.novartis investigative site|toulouse||france` — added _(2026-05-12)_ - `locations.novartis investigative site|budapest||hungary` — added _(2026-05-12)_ - `locations.novartis investigative site|szeged||hungary` — added _(2026-05-12)_ - `locations.novartis investigative site|hyderabad|andh prad|india` — added _(2026-05-12)_ - `locations.novartis investigative site|mangalore|karnataka|india` — added _(2026-05-12)_ - `locations.novartis investigative site|indore|m.p.|india` — added _(2026-05-12)_ - `locations.novartis investigative site|mumbai|maharashtra|india` — added _(2026-05-12)_ - `locations.novartis investigative site|chennai|tamil nadu|india` — added _(2026-05-12)_ - `locations.novartis investigative site|new delhi||india` — added _(2026-05-12)_ - `locations.novartis investigative site|torino|to|italy` — added _(2026-05-12)_ - `locations.novartis investigative site|palermo||italy` — added _(2026-05-12)_ - `locations.novartis investigative site|gdansk||poland` — added _(2026-05-12)_ - `locations.novartis investigative site|krakow||poland` — added _(2026-05-12)_ - `locations.novartis investigative site|lodz||poland` — added _(2026-05-12)_ - `locations.novartis investigative site|poznan||poland` — added _(2026-05-12)_ - `locations.novartis investigative site|szczecin||poland` — added _(2026-05-12)_ - `locations.novartis investigative site|warsaw||poland` — added _(2026-05-12)_ - `locations.novartis investigative site|gezina|gauteng|south africa` — added _(2026-05-12)_ - `locations.novartis investigative site|cape town||south africa` — added _(2026-05-12)_ - `locations.novartis investigative site|potchefstroom||south africa` — added _(2026-05-12)_ - `locations.novartis investigative site|pretoria||south africa` — added _(2026-05-12)_ - `locations.novartis investigative site|ankara||turkey (türkiye)` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00457626.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00457626* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*