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COMPLETED Phase 3

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

NCT00846365 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Takeda

387 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00846365

The ClinicalTrials.gov registry entry for NCT00846365 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,085 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00846365 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00846365?

The interventions under investigation include: Azilsartan medoxomil and chlorthalidone (DRUG), Olmesartan medoxomil-hydrochlorothiazide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00846365?

This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial