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NCT00591253 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Azilsartan Medoxomil in African American Participants With Essential Hypertension
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 413
- Enrollment target
NCT00591253: Completed Phase 3 study, sponsored by Takeda.
NCT00591253 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 413 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00591253, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 413 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effectiveness and safety of azilsartan medoxomil compared to placebo, once daily (QD), in African-American participants with essential hypertension.
Primary Outcome
The change in 24-hour mean systolic blood pressure measured at week 6 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.
Interventions
- DRUG Placebo
- DRUG Azilsartan medoxomil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 413 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
What the finished NCT00591253 record still lists
NCT00591253 is an interventional study that assigns participants to a tested intervention. The registered 413 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00591253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00591253 about?
NCT00591253 is a clinical study titled "Efficacy and Safety of Azilsartan Medoxomil in African American Participants With Essential Hypertension". The purpose of this study is to evaluate the effectiveness and safety of azilsartan medoxomil compared to placebo, once daily (QD), in African-American participants with essential hypertension.
What is the current status of trial NCT00591253?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 413 participants. The study started on 2007-10. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00591253?
The interventions under investigation include: Placebo (DRUG), Azilsartan medoxomil (DRUG).
Who is sponsoring clinical trial NCT00591253?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00591253's enrollment target sits among peer trials
413 905th of 2000 higher than 1,095 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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