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Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential Hypertension

NCT00696241 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1275

Last updated 2011-07-29

Study results available
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Summary

The purpose of this study is to determine the safety and efficacy of azilsartan medoxomil, once daily (QD), compared to placebo and olmesartan in participants with essential hypertension.

Conditions

Interventions

DRUG

Azilsartan medoxomil and olmesartan

Azilsartan medoxomil 20 mg, tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 weeks.

DRUG

Azilsartan medoxomil and olmesartan

Azilsartan medoxomil 40 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, for up to 6 weeks.

DRUG

Azilsartan medoxomil and olmesartan

Azilsartan medoxomil 80 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets and olmesartan 40 mg placebo-matching tablets, orally, once daily for up to 6 weeks.

DRUG

Olmesartan

Olmesartan 40 mg, tablets, azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets and azilsartan medoxomil 80 mg placebo-matching tablets, orally, once daily for up to 6 weeks.

DRUG

Placebo

Azilsartan medoxomil 20 mg placebo-matching tablets, azilsartan medoxomil 40 mg placebo-matching tablets, azilsartan medoxomil 80 mg placebo-matching tablets, and olmesartan 40 mg placebo- matching tablets, orally, once daily for up to 6 weeks.

Sponsors & Collaborators

Principal Investigators

  • VP Clinical Science Strategy · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States
  • Argentina
  • Mexico

Study Locations

More Related Trials

Entities

Drugs
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 NCT00696241 on ClinicalTrials.gov