Pharmacokinetics Following Single-dose of Valsartan in Ja... | NCT01447485

Studies
Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients

NCT01447485

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Dec 21, 2020Actual

Enrollment

12Actual

Phase

Phase 1

Conditions

Hypertension
Chronic Kidney Disease
Nephrotic Syndrome

Interventions

Valsartan (VAL489)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Aug 31, 2011

First Submission Date that Met QC Criteria

Oct 5, 2011

First Posted Date

Oct 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2020

Last Update Posted Date

Dec 21, 2020Actual

Description Module

Brief Summary

This study will assess the pharmacokinetics and safety following single dose of valsartan in Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Label	Type	Description	Intervention Names
Valsartan 20 mg or 40 mg	Experimental		Drug: Valsartan (VAL489)

Name	Type	Description	Arm Group Labels	Other Names
Valsartan (VAL489)	Drug		Valsartan 20 mg or 40 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC of valsartan in plasma		Up to 24 hours post-dose
Cmax of valsartan in plasma		Up to 24 hours post-dose
Tmax of valsartan in plasma		Up to 24 hours post-dose
T1/2 of valsartan in plasma		Up to 24 hours post-dose
CL/F of valsartan in plasma		Up to 24 hours post-dose

Secondary Outcomes

Measure	Description	Time Frame
ECG evaluations		24 hours post-dose
Standard clinical laboratory evaluations		24 hours post-dose
Vital signs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome

Exclusion Criteria:

GFR < 30 mL/min/1.73 m2
Inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenolol) from 24 hours prior to study drug administration to study completion.
Inability to safely tolerate the temporary discontinuation of any drug known or suspected to effect hepatic or renal clearance capacity from 24 hours prior to study drug administration to study completion (this includes drugs that are known to cause induction or inhibition of hepatic enzymes).

Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Aichi			Japan
Novartis Investigative Site

References Module

Citations

Not provided

ID	Term
D006973	Hypertension
D051436	Renal Insufficiency, Chronic
D009404	Nephrotic Syndrome

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D051437	Renal Insufficiency
D007674	Kidney Diseases

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds