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OpenTrials
Completed

NCT Number: NCT00171028

A Study Of Valsartan Used To Treat Hypertension For Up To 56 Weeks In Children Ages 1 - 5 Years Who Have Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

valsartan

Drug

Primary outcomes

  1. Change from baseline systolic blood pressure after 2 and 4 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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