A Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01284309
First received: January 25, 2011
Last updated: December 10, 2013
Last verified: March 2011

January 25, 2011
December 10, 2013
November 2010
February 2011   (final data collection date for primary outcome measure)
Change from baseline to Day 56 in subject-average intraocular pressure (IOP) [ Time Frame: Baseline and Day 56 ] [ Designated as safety issue: Yes ]
Day 56 data will include subjects who discontinue early due to elevated IOP
Same as current
Complete list of historical versions of study NCT01284309 on ClinicalTrials.gov Archive Site
  • Change from baseline to Day 10 in subject-average IOP [ Time Frame: Baseline and Day 10 ] [ Designated as safety issue: Yes ]
  • Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 10 [ Time Frame: Baseline and Day 10 ] [ Designated as safety issue: Yes ]
  • Number of subjects experiencing increase from baseline in a single-eye IOP by ≥6mmHg in either eye at Day 56 [ Time Frame: Baseline and Day 56 ] [ Designated as safety issue: Yes ]
  • Number of subjects experiencing increase from baseline in a single-eye IOP by≥10 mmHg in either eye at Day 10 [ Time Frame: Baseline and Day 10 ] [ Designated as safety issue: Yes ]
  • Number of subjects experiencing increase from baseline in a single-eye IOP by ≥10 mmHg in either eye at Day 56 [ Time Frame: Baseline and Day 56 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects
A Phase 1b, Randomized, Double-Masked, Parallel Group, Placebo Controlled Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Intraocular Pressure
  • Drug: Mirabegron
    oral
    Other Name: YM178
  • Drug: Placebo
    oral
  • Experimental: Mirabegron
    Intervention: Drug: Mirabegron
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
321
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Has been part of any clinical study past within 30 days or currently taking part in a clinical study other than the present study, or has participated in any previous study with mirabegron at any time
  • Ocular medication of any kind within past 30 days
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01284309
178-CL-081
No
Clinical Trials Registry, Astellas Pharma Global Development
Astellas Pharma Inc
Not Provided
Study Director: Medical Director Astellas Pharma Global Development
Astellas Pharma Inc
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP