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Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension

NCT00362115 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 449

Last updated 2011-04-19

Study results available
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Summary

The purpose of this study is to evaluate the safety, efficacy, and tolerability of azilsartan medoxomil, once daily (QD), in individuals with hypertension.

Conditions

Interventions

DRUG

Azilsartan Medoxomil

Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.

DRUG

Azilsartan Medoxomil

Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.

DRUG

Azilsartan Medoxomil

Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.

DRUG

Azilsartan Medoxomil

Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.

DRUG

Azilsartan Medoxomil

Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.

DRUG

Olmesartan

Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.

DRUG

Placebo

Matching placebo tablets, orally, once daily for up to 8 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
2006-05-31
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States
  • Argentina
  • Mexico
  • Peru

Study Locations

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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 NCT00362115 on ClinicalTrials.gov