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

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. Identifier: NCT00457626
Recruitment Status : Completed
First Posted : April 6, 2007
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: Valsartan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Safety and tolerability of valsartan in children 6 months - 5 years old with hypertension. [ Time Frame: at ever visit ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00457626

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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
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
Novartis Investigative Site
Goiania, GO, Brazil, 74605-050
Novartis Investigative Site
Recife, PE, Brazil, 50070-050
Novartis Investigative Site
Curitiba, PR, Brazil, 80250-030
Novartis Investigative Site
Marseille, France, 13385
Novartis Investigative Site
Paris Cedex 19, France, 75935
Novartis Investigative Site
Toulouse, France, 31026
Novartis Investigative Site
Budapest, Hungary, H-1083
Novartis Investigative Site
Szeged, Hungary, H-6720
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
Novartis Investigative Site
Torino, TO, Italy, 10126
Novartis Investigative Site
Palermo, Italy, 90134
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
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Izmir, Turkey, 35040
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications of Results:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00457626    
Other Study ID Numbers: CVAL489K2303E1
2006-005473-21 ( EudraCT Number )
First Posted: April 6, 2007    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
High Blood Pressure
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action