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One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension

NCT00695955 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 669

Last updated 2011-04-19

Study results available
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Summary

This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension.

Conditions

Interventions

DRUG

Azilsartan medoxomil with or without add-on chlorthalidone

Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.

DRUG

Azilsartan medoxomil with or without add-on hydrochlorothiazide

Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.

Sponsors & Collaborators

Principal Investigators

  • Executive Medical Director Clinical Science · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States
  • Chile
  • Mexico

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 NCT00695955 on ClinicalTrials.gov