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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:
ClinicalTrials.gov Identifier:
NCT00171028
First Posted: September 15, 2005
Last Update Posted: November 8, 2011
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.
Information provided by (Responsible Party):
Novartis
September 10, 2005
September 15, 2005
November 8, 2011
December 2003
November 2006   (Final data collection date for primary outcome measure)
Change from baseline systolic blood pressure after 2 and 4 weeks
Not Provided
Complete list of historical versions of study NCT00171028 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
A Study Of Valsartan Used To Treat Hypertension For Up To 56 Weeks In Children Ages 1 - 5 Years Who Have Hypertension
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Hypertension
Drug: valsartan
Not Provided
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. doi: 10.1161/HYPERTENSIONAHA.108.111054. Epub 2008 Jun 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
November 2006
November 2006   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
1 Year to 5 Years   (Child)
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00171028
CVAL489A2307
Not Provided
Not Provided
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2006

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