Trials Sponsors Conditions Drugs Pricing

Conditions

Pediatric Hypertension With or Without CKD

Keywords

Hypertension; CKD; Pediatric

Outcome Measures

Primary Outcomes (1)

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 Outcomes (3)

Change From Baseline in Mean Diastolic Blood Pressure (MDBP) at Week 6
Baseline, Week 6
Patients Achieving <90th Percentile for Age, Gender and Height at Week 6 Endpoint in Both MSBP and MDBP
Week 6
CKD Patients Achieving Urine Albumin Creatinine Ratio Percentage Reduction (UACR) >=25% at Week 6
Week 6 weeks

Study Arms (3)

Valsartan 0.25 mg/kg

EXPERIMENTAL

Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1)

Drug: VAL489Drug: VAL489 matching placebo

Valsartan 4 mg/kg

EXPERIMENTAL

Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1)

Drug: VAL489Drug: VAL489 matching placebo

Valsartan 1 mg/kg

EXPERIMENTAL

Interventions

VAL489Drug

Valsartan 3mg/kg oral solution

Also known as: Diovan

Valsartan 0.25 mg/kgValsartan 1 mg/kgValsartan 4 mg/kg

VAL489 matching placeboDrug

Valsartan 3 mg/kg oral solution

Eligibility Criteria

Age1 Year - 5 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Novartis Pharmaceuticals
Industrylead

Study Sites (27)

Novartis Investigative Site

Antwerp, 2020, Belgium

Novartis Investigative Site

Liège, 4000, Belgium

Novartis Investigative Site

Curitibia, Paraná, 80250-060, Brazil

Novartis Investigative Site

Campinas, 13087-567, Brazil

Novartis Investigative Site

Caxias do Sul, 95070-561, Brazil

Novartis Investigative Site

Porto Alegre, 90610-000, Brazil

Novartis Investigative Site

Montpellier, 34059, France

Related Publications (1)

Jankauskiene A, Drozdz D, Wasilewska A, de Paula-Bernardes R, Glazer R, Valentin M, Tan M, Chiang Y, Bapatla K. Efficacy and safety of valsartan in children aged 1-5 years with hypertension, with or without chronic kidney disease: a randomized, double-blind study followed by open-label phase. Curr Med Res Opin. 2021 Dec;37(12):2113-2122. doi: 10.1080/03007995.2021.1982681. Epub 2021 Oct 9.
PMID: 34543161DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title: Study Director
Organization: Novartis Pharmaceuticals

Study Officials

Novartis Pharmaceuticals
Novartis Pharmaceuticals
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

127 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 12, 2012

Study Start

November 8, 2012

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Valsartan 0.25 mg/kg

Valsartan 4 mg/kg

Valsartan 1 mg/kg

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (27)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Valsartan 0.25 mg/kg

Valsartan 4 mg/kg

Valsartan 1 mg/kg

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (27)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Documents

Locations