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A Study Of Valsartan Used To Treat Hypertension For Up To 13 Months In Hypertensive Children Ages 6 - 16 Years Of Age

NCT ID: NCT00171041

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2006-03-31

Brief Summary

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Drugs used to treat high blood pressure in adults should also be effective in treating high blood pressure in children and adolescents. This study will test the safety and efficacy of valsartan in treating high blood pressure in hypertensive children 6-16 years of age whose parent(s)/guardian(s) grant permission to participate.

Detailed Description

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Conditions

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Hypertension

Keywords

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PEDIATRIC HYPERTENSION PEDIATRIC VALSARTAN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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valsartan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* CHILDREN HAVE SYSTOLIC BLOOD PRESSURE AT A LEVEL =\>95th PERCENTILE FOR AGE/GENDER/HEIGHT
* CONSENT FROM PARENT(S)/GUARDIAN(S) MUST BE GRANTED

Exclusion Criteria

* BLOOD PESSURE IS =\>5% HIGHER THAN 99th PERCENTILE FOR AGE
* SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON PHYSICAL EXAMINATION, AND LABORATORY AND OTHER ASSESSMENTS
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

E.Hanover, New Jersey, United States

Site Status

Investigative Centers, , Germany

Site Status

Countries

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United States Germany

References

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Wells T, Blumer J, Meyers KE, Neto JP, Meneses R, Litwin M, Vande Walle J, Solar-Yohay S, Shi V, Han G; Valsartan Pediatric Hypertension Study Group. Effectiveness and safety of valsartan in children aged 6 to 16 years with hypertension. J Clin Hypertens (Greenwich). 2011 May;13(5):357-65. doi: 10.1111/j.1751-7176.2011.00432.x. Epub 2011 Mar 18.

Reference Type RESULT
PMID: 21545397 (View on PubMed)

Other Identifiers

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CVAL489A2302

Identifier Type: -

Identifier Source: org_study_id