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
  Purpose

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


Condition Intervention Phase
Intraocular Pressure
Drug: Mirabegron
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 321
Study Start Date: November 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mirabegron Drug: Mirabegron
oral
Other Name: YM178
Placebo Comparator: Placebo Drug: Placebo
oral

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284309

Locations
United States, Arizona
Celerion
Tempe, Arizona, United States, 85283
United States, Nebraska
Celerion
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

Additional Information:
No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier: NCT01284309     History of Changes
Other Study ID Numbers: 178-CL-081
Study First Received: January 25, 2011
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Intraocular Pressure (IOP)
YM178

Additional relevant MeSH terms:
Mirabegron
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on October 23, 2014