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Completed

NCT Number: NCT00171041

A Study Of Valsartan Used To Treat Hypertension For Up To 13 Months In Hypertensive Children Ages 6 - 16 Years Of Age

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Centers, Germany

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Who can participate

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

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.

Treatment and study plan

valsartan

Drug

Primary outcomes

  1. Change from baseline in sitting systolic blood pressure after 2 weeks

Secondary outcomes

  1. Change from baseline systolic and diastolic blood pressure after 4 weeks and 52 weeks

  2. Change from baseline systolic blood pressure after 4 weeks

  3. Change from baseline diastolic blood pressure after 2 weeks

  4. Change in diastolic blood pressure after 2 weeks to 4 weeks

  5. Change from baseline diastolic blood pressure after 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 Hypertensive Patients

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Nov 18, 2016

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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