A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)

NCT00410514 | Completed Phase 2 Results

• 1 other identifier: 178-CL-060
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 27

Brief Summary

This study examined the safety, tolerability, and efficacy of mirabegron (YM178) compared to placebo.

Conditions

Lower Urinary Tract Symptoms; Bladder Outlet Obstruction

Keywords

Beta-3 Receptor Agonist; YM178; Men; Lower Urinary Tract Symptoms; Bladder Outlet Obstruction

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)

  Maximum urinary flow rate (Qmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation. Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate.

  Baseline and Week 12

• Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)

  Detrusor pressure at maximum urinary flow rate (PdetQmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation. Least squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate.

  Baseline and Week 12

Secondary Outcomes (16)

• Change From Baseline to End of Treatment in Bladder Contractile Index (BCI)

  Baseline and Week 12

• Change From Baseline to End of Treatment in Bladder Voiding Efficiency (BVE)

  Baseline and Week 12

• Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in Postvoid Residual Volume (PVR)

  Baseline and Weeks 1, 4, 8 and 12

• Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests

  From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).

• Change From Baseline to Weeks 1, 4, 8, 12 and End of Treatment in International Prostate Symptoms Score (IPSS) Total Score

  Baseline and Weeks 1, 4, 8 and 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.

Drug: Placebo

Mirabegron 50 mg

EXPERIMENTAL

Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.

Drug: Mirabegron

Mirabegron 100 mg

EXPERIMENTAL

Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.

Drug: Mirabegron

Interventions

Mirabegron DRUG

oral

Also known as: YM178, Myrbetriq

Mirabegron 100 mg; Mirabegron 50 mg

Placebo DRUG

oral

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men 45 years of age or older
• Documented bladder outlet obstruction

You may not qualify if:

• History of urinary retention
• Symptomatic and recurrent urinary tract infection (UTI)

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (27)

Unknown Facility

Tuscon, Arizona, 85712, United States

Location

Unknown Facility

Atherton, California, 94027, United States

Location

Unknown Facility

Culver City, California, 90232, United States

Location

Unknown Facility

Fresno, California, 93720, United States

Location

Unknown Facility

San Diego, California, 92103, United States

Location

Unknown Facility

Torrance, California, 90505, United States

Location

Unknown Facility

Middlebury, Connecticut, 06762, United States

Location

Unknown Facility

Tallahassee, Florida, 32308, United States

Location

Unknown Facility

Des Moines, Iowa, 50309, United States

Location

Unknown Facility

Shreveport, Louisiana, 71106, United States

Location

Unknown Facility

Watertown, Massachusetts, 02472, United States

Location

Unknown Facility

Garden City, New York, 11530, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Cincinnati, Ohio, 45212, United States

Location

Unknown Facility

Virginia Beach, Virginia, 23454, United States

Location

Unknown Facility

Victoria, British Columbia, V8T 5G1, Canada

Location

Unknown Facility

Victoria, British Columbia, V8V 3N1, Canada

Location

Unknown Facility

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Unknown Facility

Saint John, New Brunswick, E2L 378, Canada

Location

Unknown Facility

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Unknown Facility

Kitchener, Ontario, N2N 2B9, Canada

Location

Unknown Facility

Toronto, Ontario, M4N 3M5, Canada

Location

Unknown Facility

Chicoutimi, Quebec, G7F 4A3, Canada

Location

Unknown Facility

Chicoutimi, Quebec, Canada

Location

Unknown Facility

Montreal, Quebec, H3T 1E2, Canada

Location

Unknown Facility

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Unknown Facility

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• Nitti VW, Rosenberg S, Mitcheson DH, He W, Fakhoury A, Martin NE. Urodynamics and safety of the beta(3)-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction. J Urol. 2013 Oct;190(4):1320-7. doi: 10.1016/j.juro.2013.05.062. Epub 2013 May 30.

  PMID: 23727415 BACKGROUND

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Bladder Neck Obstruction; Multiple Endocrine Neoplasia Type 1

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Male Urogenital Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Limitations and Caveats

Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Results Point of Contact

• Title: Associate Medical Director, Medical Sciences
• Organization: Astellas Pharma Global Development, Inc. (APGD)

ClinicalTrials.Disclosure@us.astellas.com

Study Officials

• Use Central Contact

  Astellas Pharma US, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2006
• First Posted: December 13, 2006
• Study Start: December 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 4, 2014
• Results First Posted: September 5, 2012

Record last verified: 2012-09

Locations

US (15); CA (12)