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NCT01199523 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Effect of Oral Mirabegron on the Heart in Healthy Males and Females

A Phase 1 study, sponsored by Astellas Pharma.

Completed
Registry status
Phase 1
Development phase
352
Enrollment target

NCT01199523: Completed Phase 1 study, sponsored by Astellas Pharma.

NCT01199523 is a Phase 1 study that has completed, run by Astellas Pharma. The registered enrollment target is 352 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (487% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01199523, a Phase 1 study, has completed, sponsored by Astellas Pharma.

COMPLETED
Registry status
Phase 1
Development phase
352 participants
Enrollment target

Study Summary

The objective of this study is to evaluate the effect of repeat oral dosing of mirabegron on ECG (electrocardiogram) measurements.

Primary Outcome

QTcI is a QT interval corrected for heart rate using individual-specific correction formula

Interventions

  • DRUG Placebo
  • DRUG mirabegron
  • DRUG moxifloxacin

Trial Details

FieldValue
Enrollment Target 352 participants
Start Date 2010-05
Est. Completion 2010-11
Phase Phase 1
Astellas Pharma

165 total trials

What the finished NCT01199523 record still lists

NCT01199523 is an interventional study that assigns participants to a tested intervention. The registered 352 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (487% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01199523 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01199523 about?

NCT01199523 is a clinical study titled "A Study to Evaluate the Effect of Oral Mirabegron on the Heart in Healthy Males and Females". The objective of this study is to evaluate the effect of repeat oral dosing of mirabegron on ECG (electrocardiogram) measurements.

What is the current status of trial NCT01199523?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 352 participants. The study started on 2010-05. Estimated completion is 2010-11.

What interventions are being tested in trial NCT01199523?

The interventions under investigation include: Placebo (DRUG), mirabegron (DRUG), moxifloxacin (DRUG).

Who is sponsoring clinical trial NCT01199523?

This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01199523's enrollment target sits among peer trials

352 95th of 2000 higher than 1,905 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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Source: ClinicalTrials.gov NCT01199523, the US trial registry maintained by the National Library of Medicine. NCT01199523 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.