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A Comparative Single-Dose Pharmacokinetic (PK) and Safety Study of Azilsartan Medoxomil in Children With Hypertension and in Healthy Adults

NCT01078376 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2014-07-25

Study results available
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Summary

The purpose of this study was to assess the pharmacokinetics (PK) and safety of a single dose of azilsartan medoxomil in children with hypertension, and comparative PK in healthy adults.

Conditions

Interventions

DRUG

Azilsartan medoxomil (TAK-491)

Azilsartan medoxomil 80 mg, tablets, orally, one day only

DRUG

Azilsartan medoxomil (TAK-491)

Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only

DRUG

Azilsartan medoxomil (TAK-491)

Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only

DRUG

Azilsartan medoxomil (TAK-491)

Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-07-31
Completion
2013-09-30

Countries

  • United States
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01078376 on ClinicalTrials.gov