Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure

Hypertension Clinical Trial

Official title:

A Randomized, Multicenter, Double-blind, 6 Week Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 6 Months - 5 Years Old With Hypertension, Followed by a 2 Week Placebo Withdrawal Period.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435162
• Other study ID #: CVAL489K2303
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2007
• Last updated: April 15, 2011
• Start date: March 2007
• Est. completion date: January 2009

Study information

• Verified date: April 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentFrance : Agence Francaise de Sécurite Sanitair des produits de santéHungary: National Institute of PharmacyItaly: The Italian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsBrazil: National Health Surveillance AgencyIndia: Central Drugs Standard Control OrganizationSouth Africa: Department of HealthTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure [SSBP] ≥ 95th percentile ).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

Inclusion Criteria:

• Children aged 6 months - 5 years at Visit 1, with a documented history of hypertension

• Must be able to swallow liquid formulation

• Must be = 6 kg or = 40 kg at randomization

• Must have documented history MSSBP (mean of 3 measurements) must be = 95th percentile for age, gender and height, at randomization

• If patients enter with uncontrolled BP they can remain on background antihypertensives with an unchanged dosing regimen

• If patients have had a solid organ transplant more than 1 year ago they must be on stable doses of immunosuppressive therapy

• Parent(s)/guardian(s) are able to follow verbal and/or written instructions in the local language

Exclusion Criteria:

• Patients with background ARB therapy

• Patients demonstrating any clinically significant abnormalities or clinically noteworthy abnormal lab values (other than those relating to renal function)

• AST/SGOT or ALT/SGPT > 3 times the upper limit of the reference range

• Glomerular filtration rate < 30 mL/min/1.73m²

• Serum potassium > upper limit of the reference range

• MSSBP = 25% above the 95th percentile

• Patients exhibiting clinically significant ECG abnormalities

• Patients that have coarctation of the aorta with a gradient of = 30 mm Hg, or renal artery stenosis

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Valsartan 0.25 mg/kg
once daily
• Valsartan 1.0 mg/kg
once daily
• Valsartan 4.0 mg/kg
once daily

Locations

Country	Name	City	State
Belgium	Sites in Belgium	Belgium
Brazil	Sites in Brazil	Brazil
France	Sites in France	Paris
Hungary	Sites in Hungary	Hungary
India	Sites in India	India
Italy	sites in Italy	Italy
Poland	Sites in Poland	Poland
South Africa	Sites in South Africa	South Africa
Sweden	Sites in Sweden	Sweden
Turkey	Sites in Turkey	Turkey
United States	Sites in USA	USA	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)		baseline and week 6	No
Secondary	Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)		baseline and week 6	No
Secondary	Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8)		week 6 and week 8	No
Secondary	Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8)		week 6 and week 8	No