A Study Of Valsartan Used To Treat Hypertension For Up To 56 Weeks In Children Ages 1 - 5 Years Who Have Hypertension

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00171028

First received: September 10, 2005

Last updated: November 7, 2011

Last verified: June 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

September 10, 2005

Last Updated Date

November 7, 2011

Start Date ^ICMJE

December 2003

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline systolic blood pressure after 2 and 4 weeks

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00171028 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline systolic blood pressure after 4 weeks
Change from baseline diastolic blood pressure after 2 weeks
Change in 2 week diastolic blood pressure after 2 more weeks
Change in baseline diastolic blood pressure after 4 weeks
Adverse events, serious adverse events, and laboratory values during 4 weeks

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study Of Valsartan Used To Treat Hypertension For Up To 56 Weeks In Children Ages 1 - 5 Years Who Have Hypertension

Official Title ^ICMJE

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 Hypertension Patients 1 - 5 Years Of Age

Brief Summary

Drugs used to treat hypertension in adults should also be effective in treating high blood pressure in infants and children. This study will test the safety and efficacy of valsartan in lowering blood pressure in children 1 - 5 years old whose parents grant permission to participate.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: valsartan

Study Arm (s)

Not Provided

Publications *

Flynn JT, Meyers KE, Neto JP, de Paula Meneses R, Zurowska A, Bagga A, Mattheyse L, Shi V, Gupte J, Solar-Yohay S, Han G; Pediatric Valsartan Study Group. Efficacy and safety of the Angiotensin receptor blocker valsartan in children with hypertension aged 1 to 5 years. Hypertension. 2008 Aug;52(2):222-8. Epub 2008 Jun 30.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2006

Primary Completion Date

November 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

CHILDREN HAVE BLOOD PRESSURE LEVEL =>95TH PERCENTILE FOR AGE,GENDER & HEIGHT
PARENTAL CONSENT MUST BE GRANTED

Exclusion Criteria:

BLOOD PESSURE IS =>25% HIGHER THAN 95TH PERCENTILE FOR AGE, GENDER & HEIGHT
SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON EXAMINATION AND LABORATORY OR OTHER ASSESSMENTS

Other protocol-defined exclusion criteria will apply.

Gender

Both

Ages

1 Year to 5 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00171028

Other Study ID Numbers ^ICMJE

CVAL489A2307

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

June 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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