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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Valsartan 4.0 mg/kg; Drug: Valsartan 0.25 mg/kg; Drug: Valsartan 1.0 mg/kg

• Registration Number: NCT00435162
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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 ).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-13
• Study First Submitted QC: 2007-02-13
• Study First Posted: 2007-02-14
• Study Start: 2007-03
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2010-12-17
• Disposition First Submitted: 2010-12-17
• Status Verified: 2011-04
• Results First Submitted QC: 2011-04-15
• Disposition First Submitted QC: 2011-04-15
• Last Update Submitted: 2011-04-15
• Results First Posted: 2011-05-09
• Disposition First Posted: 2011-05-09
• Last Update Posted: 2011-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose	Valsartan 4.0 mg/kg	-
Low Dose	Valsartan 0.25 mg/kg	-
Medium Dose	Valsartan 1.0 mg/kg	-

Primary Outcome Measures

Name	Time	Method
Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)	baseline and week 6

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)	baseline and week 6
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
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

Trial Locations

Locations (11)

Sites in USA; 🇺🇸 USA, New Jersey, United States

Sites in India; 🇮🇳 India, India

Sites in Brazil; 🇧🇷 Brazil, Brazil

sites in Italy; 🇮🇹 Italy, Italy

Sites in Poland; 🇵🇱 Poland, Poland

Sites in Turkey; 🇹🇷 Turkey, Turkey

Sites in Sweden; 🇸🇪 Sweden, Sweden

Sites in Belgium; 🇧🇪 Belgium, Belgium

Sites in South Africa; 🇿🇦 South Africa, South Africa

Sites in Hungary; 🇭🇺 Hungary, Hungary

Sites in France; 🇫🇷 Paris, France