An Open Label Extension Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00457626
First received: April 5, 2007
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.


Condition Intervention Phase
Hypertension
Drug: Valsartan
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Extension Study to Evaluate Safety, Tolerability, and Efficacy of 18 Weeks of Valsartan Treatment in Children 6 Months-5 Years Old With Hypertension

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability of valsartan in children 6 months - 5 years old with hypertension. [ Time Frame: at ever visit ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: April 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valsartan Drug: Valsartan
All patients started with dose 1 mg/kg once daily for first 2 weeks, up-titration to 2mg/kg (then to 4mg/kg) depending on MSSBP.

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Patients who qualified and entered the core study.
  • Patients who participated in the core study, completed period 1 and were re-randomized in period 2 and continued for at least 3 days in period 2.

Exclusion criteria

  • Patients who did not complete period 1 of the core study.
  • Patients who were re-randomized in period 2 of core study but did not continue for => 3 days in period 2 of the core study.
  • Patients who experienced any adverse events considered serious or drug related in the core study.
  • Patients excluded from the core study.
  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: NCT00457626

  Hide Study Locations
Locations
United States, New Jersey
Novartis Investigative Site
Hackensack, New Jersey, United States, 07601
United States, Pennsylvania
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Novartis Investigative Site
Norfolk, Virginia, United States, 23510
Belgium
Novartis Investigative Site
Antwerpen, Belgium, 2020
Novartis Investigative Site
Edegem, Belgium, 2650
Novartis Investigative Site
Gent, Belgium, 9000
Novartis Investigative Site
Laeken, Belgium, 1020
Novartis Investigative Site
Liege, Belgium, 4000
Brazil
Novartis Investigative Site
Goiania, GO, Brazil, 74605-050
Novartis Investigative Site
Recife, PE, Brazil, 50070-050
Novartis Investigative Site
Curitiba, PR, Brazil, 80250-030
France
Novartis Investigative Site
Marseille, France, 13385
Novartis Investigative Site
Paris Cedex 19, France, 75935
Novartis Investigative Site
Toulouse, France, 31026
Hungary
Novartis Investigative Site
Budapest, Hungary, H-1083
Novartis Investigative Site
Szeged, Hungary, H-6720
India
Novartis Investigative Site
Hyderabad, Andh Prad, India, 500033
Novartis Investigative Site
Mangalore, Karnataka, India, 575001
Novartis Investigative Site
Indore, M.p., India, 425001
Novartis Investigative Site
Mumbai, Maharashtra, India, 400026
Novartis Investigative Site
Chennai, Tamil Nadu, India, 600008
Novartis Investigative Site
New Delhi, India, 110 029
Italy
Novartis Investigative Site
Torino, TO, Italy, 10126
Novartis Investigative Site
Palermo, Italy, 90134
Poland
Novartis Investigative Site
Gdansk, Poland, 80-952
Novartis Investigative Site
Krakow, Poland, 30-663
Novartis Investigative Site
Lodz, Poland, 93-338
Novartis Investigative Site
Poznan, Poland, 60-572
Novartis Investigative Site
Szczecin, Poland, 70-410
Novartis Investigative Site
Warszawa, Poland, 04-730
South Africa
Novartis Investigative Site
Gezina, Pretoria, Gauteng, South Africa, 0084
Novartis Investigative Site
Cape Town, South Africa, 7505
Novartis Investigative Site
Potchefstroom, South Africa
Novartis Investigative Site
Pretoria, South Africa, 0002
Turkey
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Izmir, Turkey, 35040
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00457626     History of Changes
Other Study ID Numbers: CVAL489K2303E1, 2006-005473-21
Study First Received: April 5, 2007
Last Updated: November 30, 2012
Health Authority: United States: Food and Drug Administration
Belgium : Federal Public Service, Health, Food Chain Safety & Environment
France : Agence Francaise de Sécurite Sanitair des produits de santé
Hungary: National Institute of Pharmacy
Italy : Italian Medicines Agency
Poland : The Office for Registration of Medicinal Products,Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Brazil: National Health Surveillance Agency
India : Central Drug Standard Control Organization
South Africa : Department of Health Affairs
Turkey : Turkey Ministry of Health

Keywords provided by Novartis:
Children
pediatrics
High Blood Pressure
Hypertension
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