NCT00435162

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 ).

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Mar 2007

Typical duration for phase_3 hypertension

Geographic Reach
11 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2007

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 9, 2011

Completed
Last Updated

May 9, 2011

Status Verified

April 1, 2011

Enrollment Period

1.8 years

First QC Date

February 13, 2007

Results QC Date

December 17, 2010

Last Update Submit

April 15, 2011

Conditions

Hypertension

Keywords

ChildrenpediatricsHigh Blood PressureHypertensionValsartan

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)

    baseline and week 6

Secondary Outcomes (3)

  • 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

Study Arms (3)

Low Dose

EXPERIMENTAL
Drug: Valsartan 0.25 mg/kg

Medium Dose

EXPERIMENTAL
Drug: Valsartan 1.0 mg/kg

High Dose

EXPERIMENTAL
Drug: Valsartan 4.0 mg/kg

Interventions

Valsartan 0.25 mg/kgDRUG

once daily

Low Dose
Valsartan 1.0 mg/kgDRUG

once daily

Medium Dose
Valsartan 4.0 mg/kgDRUG

once daily

High Dose

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Sites in USA

USA, New Jersey, United States

Location

Sites in Belgium

Belgium, Belgium

Location

Sites in Brazil

Brazil, Brazil

Location

Sites in France

Paris, France

Location

Sites in Hungary

Hungary, Hungary

Location

Sites in India

India, India

Location

sites in Italy

Italy, Italy

Location

Sites in Poland

Poland, Poland

Location

Sites in South Africa

South Africa, South Africa

Location

Sites in Sweden

Sweden, Sweden

Location

Sites in Turkey

Turkey, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Sponsor GmbH

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 13, 2007

First Posted

February 14, 2007

Study Start

March 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

May 9, 2011

Results First Posted

May 9, 2011

Record last verified: 2011-04

Locations

IT(1)HU(1)ZA(1)PL(1)SE(1)BE(1)BR(1)FR(1)US(1)TU(1)IN(1)