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.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171041
First received: September 10, 2005
Last updated: November 7, 2011
Last verified: November 2011
  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 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 Hypertensive Patients

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014