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NCT01496430 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Azilsartan Medoxomil Used in Combination With Metformin in Participants With Hypertension and Diabetes
A Phase 3 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 3
- Development phase
- 105
- Enrollment target
NCT01496430: Clinical Trial Phase 3 study, sponsored by Takeda.
NCT01496430 is a Phase 3 study that was terminated before completion, run by Takeda. The registered enrollment target is 105 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01496430, a Phase 3 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 105 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in stage 1 hypertensive, type 2 diabetes mellitus (T2DM) participants whose glycemic control was inadequate on metformin alone.
Primary Outcome
The change in trough systolic blood pressure measured at week 8 relative to baseline. The trough is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.
Interventions
- DRUG Placebo
- DRUG Azilsartan medoxomil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
Why NCT01496430 stopped before completion
NCT01496430 is an interventional study that assigns participants to a tested intervention. The registered 105 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 (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01496430 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01496430 about?
NCT01496430 is a clinical study titled "Efficacy and Safety of Azilsartan Medoxomil Used in Combination With Metformin in Participants With Hypertension and Diabetes". The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in stage 1 hypertensive, type 2 diabetes mellitus (T2DM) participants whose glycemic control was inadequate on metformin...
What is the current status of trial NCT01496430?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 105 participants. The study started on 2012-01. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01496430?
The interventions under investigation include: Placebo (DRUG), Azilsartan medoxomil (DRUG).
Who is sponsoring clinical trial NCT01496430?
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 NCT01496430's enrollment target sits among peer trials
105 1670th of 2000 higher than 330 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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