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NCT00846365 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Azilsartan Medoxomil Plus Chlorthalidone in Participants With Moderate to Severe Hypertension

A Phase 3 study of Essential Hypertension, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
1,085
Enrollment target
20
Study locations

NCT00846365: Completed Phase 3 study of Essential Hypertension, sponsored by Takeda.

NCT00846365 is a Phase 3 study of Essential Hypertension that has completed, run by Takeda. The registered enrollment target is 1,085 participants, above the 668-participant average among 8 other Essential Hypertension trials with a reported enrollment target (62% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00846365, a Phase 3 study of Essential Hypertension, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
1,085 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil combined with chlorthalidone, once daily (QD), in participants with moderate to severe essential hypertension.

Primary Outcome

The change in trough systolic blood pressure measured at week 8 or final visit relative to baseline. Systolic blood pressure is the average of the 3 serial trough sitting systolic blood pressure measurements.

Conditions Studied

Interventions

  • DRUG Azilsartan medoxomil and chlorthalidone
  • DRUG Olmesartan medoxomil-hydrochlorothiazide

Study Locations (20)

Florida

  • - Clearwater
  • - Jacksonville
  • - Jupiter
  • - Miami
  • - Ocala
  • - Pembroke Pines
  • - Plant City

Alabama

  • - Birmingham
  • - Haleyville
  • - Hueytown
  • - Jasper
  • - Tallassee

California

  • - Long Beach
  • - National City
  • - Roseville
  • - San Francisco
  • - San Jose

Arizona

  • - Green Valley
  • - Phoenix

Delaware

  • - Newark

Trial Details

FieldValue
Enrollment Target 1,085 participants
Start Date 2009-03
Est. Completion 2010-06
Phase Phase 3
Takeda

408 total trials

What the finished NCT00846365 record still lists

NCT00846365 is an interventional study that assigns participants to a tested intervention. Its 1,085 participants enrollment target places it among the larger protocols in the corpus, above the 668-participant average among 8 other Essential Hypertension trials with a reported enrollment target (62% higher).

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

NCT00846365 names 20 study sites across 5 states, led by Florida, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT00846365 about?

NCT00846365 is a clinical study titled "Efficacy and Safety of Azilsartan Medoxomil Plus Chlorthalidone in Participants With Moderate to Severe Hypertension". The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil combined with chlorthalidone, once daily (QD), in participants with moderate to severe essential hypertension.

What is the current status of trial NCT00846365?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,085 participants. The study started on 2009-03. Estimated completion is 2010-06.

What conditions does trial NCT00846365 study?

This clinical trial studies the following conditions: Essential Hypertension.

What interventions are being tested in trial NCT00846365?

The interventions under investigation include: Azilsartan medoxomil and chlorthalidone (DRUG), Olmesartan medoxomil-hydrochlorothiazide (DRUG).

Who is sponsoring clinical trial NCT00846365?

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

Where is trial NCT00846365 being conducted?

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

Similar trials for Essential 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 NCT00846365's enrollment target sits among peer trials

1,085 3rd of 8 higher than 6 of 8 other Essential Hypertension trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Essential 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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Source: ClinicalTrials.gov NCT00846365, the US trial registry maintained by the National Library of Medicine. NCT00846365 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.