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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457626
• Other study ID #: CVAL489K2303E1
• Secondary ID: 2006-005473-21
• Status: Completed
• Phase: Phase 3
• Start date: April 9, 2007
• Est. completion date: May 25, 2009

Study information

• Verified date: September 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 25, 2009
• Est. primary completion date: May 25, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Valsartan
Extemporaneous suspension of valsartan, orally.

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Antwerpen
Belgium	Novartis Investigative Site	Edegem
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Laeken
Belgium	Novartis Investigative Site	Liege
Brazil	Novartis Investigative Site	Curitiba	PR
Brazil	Novartis Investigative Site	Goiania	GO
Brazil	Novartis Investigative Site	Recife	PE
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Paris Cedex 19
France	Novartis Investigative Site	Toulouse
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Szeged
India	Novartis Investigative Site	Chennai	Tamil Nadu
India	Novartis Investigative Site	Hyderabad	Andh Prad
India	Novartis Investigative Site	Indore	M.p.
India	Novartis Investigative Site	Mangalore	Karnataka
India	Novartis Investigative Site	Mumbai	Maharashtra
India	Novartis Investigative Site	New Delhi
Italy	Novartis Investigative Site	Palermo
Italy	Novartis Investigative Site	Torino	TO
Poland	Novartis Investigative Site	Gdansk
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Szczecin
Poland	Novartis Investigative Site	Warszawa
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Gezina	Gauteng
South Africa	Novartis Investigative Site	Potchefstroom
South Africa	Novartis Investigative Site	Pretoria
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Izmir
United States	Novartis Investigative Site	Hackensack	New Jersey
United States	Novartis Investigative Site	Norfolk	Virginia
United States	Novartis Investigative Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  France,  Hungary,  India,  Italy,  Poland,  South Africa,  Turkey, 

References & Publications (1)

Schaefer F, Coppo R, Bagga A, Senguttuvan P, Schlosshauer R, Zhang Y, Kadwa M. Efficacy and safety of valsartan in hypertensive children 6 months to 5 years of age. J Hypertens. 2013 May;31(5):993-1000. doi: 10.1097/HJH.0b013e32835f5721. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)	Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sitting systolic blood pressure (SSBP) measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement.	Baseline to Week 26
Primary	Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)	Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participant remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three SDBP measurements were used as the average sitting office blood pressure for that visit. Negative change from Baseline indicates improvement.	Baseline to Week 26
Primary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.	Week 8 to Week 26 of Extension Phase