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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
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: valsartan
 Phase 3

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 Hypertension Patients 1 - 5 Years Of Age

Resource links provided by NLM:

Drug Information available for: Valsartan
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline systolic blood pressure after 2 and 4 weeks

Secondary Outcome Measures:
  • 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

Enrollment: 90
Study Start Date: December 2003
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171028

Locations
United States, New Jersey
Novartis Pharmaceuticals
E. Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171028     History of Changes
Other Study ID Numbers: CVAL489A2307
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 May 22, 2013