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NCT00591266 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Azilsartan Medoxomil, Once Daily (QD), Co-Administered With Amlodipine in Participants With Essential Hypertension
A Phase 3 study of Hypertension, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 566
- Enrollment target
- 20
- Study locations
NCT00591266: Completed Phase 3 study of Hypertension, sponsored by Takeda.
NCT00591266 is a Phase 3 study of Hypertension that has completed, run by Takeda. The registered enrollment target is 566 participants, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00591266, a Phase 3 study of Hypertension, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 566 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), co-administered with amlodipine in treating individuals with essential hypertension, compared to treatment with amlodipine alone.
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.
Conditions Studied
Interventions
- DRUG Amlodipine
- DRUG Azilsartan Medoxomil and amlodipine
Study Locations (20)
California
- - Anaheim
- - Beverly Hills
- - Burbank
- - Burlingame
- - La Jolla
- - Orange
- - Roseville
- - Tustin
Florida
- - Hialeah
- - Longwood
- - Tampa
Arizona
- - Mesa
- - Phoenix
Illinois
- - Chicago
- - Gurnee
Colorado
- - Wheat Ridge
Delaware
- - Newark
District of Columbia
- - Washington D.C.
Hawaii
- - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 566 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
What the finished NCT00591266 record still lists
NCT00591266 is an interventional study that assigns participants to a tested intervention. The registered 566 participants enrollment target is mid-sized for trials with a published cap, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Amlodipine is the first listed.
NCT00591266 names 20 study sites across 9 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT00591266 about?
NCT00591266 is a clinical study titled "Efficacy and Safety of Azilsartan Medoxomil, Once Daily (QD), Co-Administered With Amlodipine in Participants With Essential Hypertension". The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), co-administered with amlodipine in treating individuals with essential hypertension, compared to treatment with amlodipine alone.
What is the current status of trial NCT00591266?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 566 participants. The study started on 2007-10. Estimated completion is 2009-04.
What conditions does trial NCT00591266 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT00591266?
The interventions under investigation include: Amlodipine (DRUG), Azilsartan Medoxomil and amlodipine (DRUG).
Who is sponsoring clinical trial NCT00591266?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00591266 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00591266's enrollment target sits among peer trials
566 104th of 470 higher than 367 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.
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