A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension

Completed · Phase 3

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00457626

Run by

Novartis Pharmaceuticals

People needed

66

Starts

2007-04-09

Expected to finish

2009-05-25

Last updated by the study team

2021-09-05

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who qualified and entered the core study.
• Participants 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.

You may not qualify if…

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

Where it is running

• Novartis Investigative Site — Hackensack, New Jersey, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Norfolk, Virginia, United States
• Novartis Investigative Site — Antwerp, Belgium
• Novartis Investigative Site — Edegem, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Laken, Belgium
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Goiânia, Goiás, Brazil
• Novartis Investigative Site — Curitiba, Paraná, Brazil
• Novartis Investigative Site — Recife, Pernambuco, Brazil
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Szeged, Hungary
• Novartis Investigative Site — Hyderabad, Andh Prad, India
• Novartis Investigative Site — Mangalore, Karnataka, India
• Novartis Investigative Site — Indore, M.P., India
• Novartis Investigative Site — Mumbai, Maharashtra, India
• Novartis Investigative Site — Chennai, Tamil Nadu, India
• Novartis Investigative Site — New Delhi, India
• Novartis Investigative Site — Torino, TO, Italy
• Novartis Investigative Site — Palermo, Italy
• Novartis Investigative Site — Gdansk, Poland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.