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

This study has been completed.

First Received on September 10, 2005. Last Updated on November 7, 2011 History of Changes

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00171041

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: valsartan	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in sitting systolic blood pressure after 2 weeks

Secondary Outcome Measures:

Change from baseline systolic and diastolic blood pressure after 4 weeks and 52 weeks
Change from baseline systolic blood pressure after 4 weeks
Change from baseline diastolic blood pressure after 2 weeks
Change in diastolic blood pressure after 2 weeks to 4 weeks
Change from baseline diastolic blood pressure after 4 weeks

Enrollment:	265
Study Start Date:	December 2002
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	6 Years to 16 Years
Genders Eligible for Study:	Both

Criteria

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

Other protocol-defined inclusion/exclusion criteria will also apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171041

Locations

United States, New Jersey
Novartis Pharmaceuticals
E.Hanover, New Jersey, United States, 07936
Germany

Investigative Centers, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00171041 History of Changes
Other Study ID Numbers:	CVAL489A2302
Study First Received:	September 10, 2005
Last Updated:	November 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

PEDIATRIC HYPERTENSION
PEDIATRIC
VALSARTAN

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012