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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00171028
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: valsartan Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : December 2003
Primary Completion Date : November 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

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

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. Change from baseline systolic blood pressure after 4 weeks
  2. Change from baseline diastolic blood pressure after 2 weeks
  3. Change in 2 week diastolic blood pressure after 2 more weeks
  4. Change in baseline diastolic blood pressure after 4 weeks
  5. Adverse events, serious adverse events, and laboratory values during 4 weeks

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: June 2006

Keywords provided by Novartis:
PEDIATRIC HYPERTENSION
PEDIATRIC
VALSARTAN

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action