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NCT01078376 · ClinicalTrials.gov registry record · Phase 1
A Comparative Single-Dose Pharmacokinetic (PK) and Safety Study of Azilsartan Medoxomil in Children With Hypertension and in Healthy Adults
A Phase 1 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT01078376: Clinical Trial Phase 1 study, sponsored by Takeda.
NCT01078376 is a Phase 1 study that was terminated before completion, run by Takeda. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01078376, a Phase 1 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
The purpose of this study was to assess the pharmacokinetics (PK) and safety of a single dose of azilsartan medoxomil in children with hypertension, and comparative PK in healthy adults.
Primary Outcome
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
Interventions
- DRUG Azilsartan medoxomil (TAK-491)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2010-05 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
Why NCT01078376 stopped before completion
NCT01078376 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 1 intervention - of which Azilsartan medoxomil (TAK-491) is the first listed.
NCT01078376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01078376 about?
NCT01078376 is a clinical study titled "A Comparative Single-Dose Pharmacokinetic (PK) and Safety Study of Azilsartan Medoxomil in Children With Hypertension and in Healthy Adults". The purpose of this study was to assess the pharmacokinetics (PK) and safety of a single dose of azilsartan medoxomil in children with hypertension, and comparative PK in healthy adults.
What is the current status of trial NCT01078376?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2010-05. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01078376?
The interventions under investigation include: Azilsartan medoxomil (TAK-491) (DRUG).
Who is sponsoring clinical trial NCT01078376?
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 NCT01078376's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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