NCT01284309

Brief Summary

The purpose of this study is to assess the affect of mirabegron on intraocular pressure (IOP) in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

December 11, 2013

Status Verified

March 1, 2011

Enrollment Period

3 months

First QC Date

January 25, 2011

Last Update Submit

December 10, 2013

Conditions

Intraocular Pressure

Keywords

Intraocular Pressure (IOP)YM178

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to Day 56 in subject-average intraocular pressure (IOP)

    Day 56 data will include subjects who discontinue early due to elevated IOP

    Baseline and Day 56

Secondary Outcomes (5)

  • Change from baseline to Day 10 in subject-average IOP

    Baseline and Day 10

  • Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 10

    Baseline and Day 10

  • Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 56

    Baseline and Day 56

  • Number of subjects experiencing increase from baseline in a single-eye IOP by≥10 mmHg in either eye at Day 10

    Baseline and Day 10

  • Number of subjects experiencing increase from baseline in a single-eye IOP by ≥10 mmHg in either eye at Day 56

    Baseline and Day 56

Study Arms (2)

Mirabegron

EXPERIMENTAL
Drug: Mirabegron

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MirabegronDRUG

oral

Also known as: YM178
Mirabegron
PlaceboDRUG

oral

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female subject must be either post-menopausal (defined as at least 2 years without menses) or surgically sterile (at least 1 month) or of childbearing potential with contraception. All women of childbearing potential will be required to use contraception consisting of two forms of birth control (one of which must be a barrier method), must not be lactating, and must not be breastfeeding during the study period and for 30 days after final study drug administration. All women of childbearing potential must have a negative urine pregnancy test
  • Male subject with female spouses/partners who are of childbearing potential must use contraception consisting of two forms of birth control (one of which must be a barrier method) during the study period
  • Subject may either be otherwise healthy or have symptoms of overactive bladder by self-report

You may not qualify if:

  • History of glaucoma or ocular hypertension
  • Abnormal visual field in either eye
  • Ophthalmic condition that would interfere with reliable Goldmann tonometry (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca)
  • History of major ocular infection, inflammation, or herpes simplex keratitis; evidence of current clinically significant blepharitis or conjunctivitis
  • Any history of ocular surgery including refractive surgery such as laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) in any eye
  • Ocular trauma within the past six months
  • Severe myopia
  • Diabetes, Type I or Type 2, with or without medical management
  • Cardiovascular disease requiring pharmacotherapy
  • History of any type of dysrhythmia
  • Systemic hypertension requiring pharmacotherapy
  • Past diagnosis of any connective tissue or autoimmune disease including rheumatoid arthritis and spondyloarthropathies
  • History of psychiatric illness requiring hospitalization
  • Recent history (within past 24 months) of alcohol or other substance abuse (with the exception of nicotine)
  • Used tobacco-containing products or nicotine-containing products within past 3 months
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Celerion

Tempe, Arizona, 85283, United States

Location

Celerion

Lincoln, Nebraska, 68502, United States

Location

Related Publications (1)

  • Novack GD, Lewis RA, Vogel R, Sheth N, Swearingen D, Rasmussen S, Hantsbarger G, Martin NE. Randomized, double-masked, placebo-controlled study to assess the ocular safety of mirabegron in healthy volunteers. J Ocul Pharmacol Ther. 2013 Sep;29(7):674-80. doi: 10.1089/jop.2012.0254. Epub 2013 Apr 15.

    PMID: 23586728DERIVED

MeSH Terms

Interventions

mirabegron

Study Officials

  • Medical Director

    Astellas Pharma Global Development

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 25, 2011

First Posted

January 27, 2011

Study Start

November 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

December 11, 2013

Record last verified: 2011-03

Locations

US(2)