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NCT00591578 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Hypertension, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
984
Enrollment target
20
Study locations

NCT00591578: Completed Phase 3 study of Hypertension, sponsored by Takeda.

NCT00591578 is a Phase 3 study of Hypertension that has completed, run by Takeda. The registered enrollment target is 984 participants, below the 3,505-participant average among 470 other Hypertension trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00591578, a Phase 3 study of Hypertension, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
984 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

The change in 24-hour mean systolic blood pressure measured at week 24 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.

Conditions Studied

Hypertension

Interventions

  • DRUG Valsartan
  • DRUG Azilsartan Medoxomil

Study Locations (20)

California

  • - Beverly Hills
  • - Burbank
  • - La Jolla
  • - Long Beach
  • - Los Angeles
  • - Paramount
  • - San Diego
  • - Santa Monica
  • - Spring Valley
  • - Tustin
  • - Vista
  • - Westlake Village

Arizona

  • - Glendale
  • - Phoenix
  • - Scottsdale
  • - Tuscon

Alabama

  • - Huntsville

Connecticut

  • - Ridgefield

Delaware

  • - Newark

District of Columbia

  • - Washington D.C.

Trial Details

FieldValue
Enrollment Target 984 participants
Start Date 2007-12
Est. Completion 2010-03
Phase Phase 3
Takeda

408 total trials

What the finished NCT00591578 record still lists

NCT00591578 is an interventional study that assigns participants to a tested intervention. The registered 984 participants enrollment target is mid-sized for trials with a published cap, below the 3,505-participant average among 470 other Hypertension trials with a reported enrollment target (72% lower).

The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Valsartan is the first listed.

NCT00591578 names 20 study sites across 6 states, led by California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT00591578 about?

NCT00591578 is a clinical study titled "Efficacy and Safety Comparison of Azilsartan Medoxomil to Valsartan in Participants With Essential Hypertension". 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.

What is the current status of trial NCT00591578?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 984 participants. The study started on 2007-12. Estimated completion is 2010-03.

What conditions does trial NCT00591578 study?

This clinical trial studies the following conditions: Hypertension.

What interventions are being tested in trial NCT00591578?

The interventions under investigation include: Valsartan (DRUG), Azilsartan Medoxomil (DRUG).

Who is sponsoring clinical trial NCT00591578?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00591578 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Hypertension

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00591578's enrollment target sits among peer trials

984 77th of 470 higher than 394 of 470 other Hypertension trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00591578, the US trial registry maintained by the National Library of Medicine. NCT00591578 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.