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

Condition(s) targeted: Hypertension

Intervention: Valsartan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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.

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety and tolerability of valsartan in children 6 months - 5 years old with hypertension.

Minimum age: 6 Months. Maximum age: 5 Years. Gender(s): Both.

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.

Novartis Investigative Site, Antwerpen 2020, Belgium

Novartis Investigative Site, Edegem 2650, Belgium

Novartis Investigative Site, Gent 9000, Belgium

Novartis Investigative Site, Laeken 1020, Belgium

Novartis Investigative Site, Liege 4000, Belgium

Novartis Investigative Site, Marseille 13385, France

Novartis Investigative Site, Paris Cedex 19 75935, France

Novartis Investigative Site, Toulouse 31026, France

Novartis Investigative Site, Budapest H-1083, Hungary

Novartis Investigative Site, Szeged H-6720, Hungary

Novartis Investigative Site, New Delhi 110 029, India

Novartis Investigative Site, Palermo 90134, Italy

Novartis Investigative Site, Gdansk 80-952, Poland

Novartis Investigative Site, Krakow 30-663, Poland

Novartis Investigative Site, Lodz 93-338, Poland

Novartis Investigative Site, Poznan 60-572, Poland

Novartis Investigative Site, Szczecin 70-410, Poland

Novartis Investigative Site, Warszawa 04-730, Poland

Novartis Investigative Site, Cape Town 7505, South Africa

Novartis Investigative Site, Potchefstroom, South Africa

Novartis Investigative Site, Pretoria 0002, South Africa

Novartis Investigative Site, Ankara 06100, Turkey

Novartis Investigative Site, Izmir 35040, Turkey

Novartis Investigative Site, Hyderabad, Andh Prad 500033, India

Novartis Investigative Site, Goiania, GO 74605-050, Brazil

Novartis Investigative Site, Gezina, Pretoria, Gauteng 0084, South Africa

Novartis Investigative Site, Mangalore, Karnataka 575001, India

Novartis Investigative Site, Indore, M.p. 425001, India

Novartis Investigative Site, Mumbai, Maharashtra 400026, India

Novartis Investigative Site, Hackensack, New Jersey 07601, United States

Novartis Investigative Site, Recife, PE 50070-050, Brazil

Novartis Investigative Site, Curitiba, PR 80250-030, Brazil

Novartis Investigative Site, Philadelphia, Pennsylvania 19104, United States

Novartis Investigative Site, Torino, TO 10126, Italy

Novartis Investigative Site, Chennai, Tamil Nadu 600008, India

Novartis Investigative Site, Norfolk, Virginia 23510, United States

Starting date: April 2007
Last updated: November 30, 2012