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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457626

  Show 36 Study Locations
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
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014