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Efficacy and Safety Comparison of Azilsartan Medoxomil to Valsartan in Participants With Essential Hypertension

NCT00591578 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 984

Last updated 2012-02-02

Study results available
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Summary

The purpose of this study is to compare the efficacy and safety of TAK-491 (azilsartan medoxomil), once daily (QD), to valsartan in participants with essential hypertension.

Conditions

Interventions

DRUG

Azilsartan Medoxomil

Azilsartan Medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.

DRUG

Azilsartan Medoxomil

Azilsartan Medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.

DRUG

Valsartan

Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.

Sponsors & Collaborators

Principal Investigators

  • Executive Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-09-30
Completion
2010-03-31

Countries

  • United States
  • Chile
  • Mexico
  • Peru

Study Locations

More Related Trials

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 NCT00591578 on ClinicalTrials.gov