Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction

NCT00507455 | Completed Phase 2 Results

• 2 other identifiers: 905-CL-0582007-001268-57
• Study Type: interventional
• Target: 222
• Locations: 6 countries
• Sites: 33

Brief Summary

A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).

Conditions

Lower Urinary Tract Symptoms; Bladder Outlet Obstruction

Keywords

Lower Urinary Tract Symptoms; Bladder Outlet Obstruction; Treatment; Solifenacin Succinate; Tamsulosin hydrochloride

Outcome Measures

Primary Outcomes (2)

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

  Detrusor pressure (Pdet) measures the force the detrusor muscle is exerting. This pressure is required to expel urine from the bladder during normal voiding. A high detrusor pressure may be observed in the presence of outflow tract obstruction. Detrusor pressure at maximum urinary flow rate (PdetQmax) was evaluated using simultaneous recording of urinary voiding by an uroflowmeter during detrusor pressure evaluation by cystometry.

  Baseline and Week 12

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

  The maximum flow rate (Qmax) during a micturition (urination) was recorded using uroflowmetry. A reduction in maximum flow rate may be due to an obstruction of the bladder outlet or a failure of the detrusor muscle to aid in expelling urine.

  Baseline and Week 12

Secondary Outcomes (16)

• Change From Baseline in Post Void Residual Volume (PVR)

  Baseline and Weeks 2, 4, 8 and 12

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

  Baseline and Week 12

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

  Baseline and Week 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 in International Prostate Symptoms Score (IPSS)

  Baseline and Weeks 2, 4, 8 and 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.

Drug: Placebo to solifenacin; Drug: Placebo to tamsulosin

6 mg Solifenacin + 0.4 mg Tamsulosin

EXPERIMENTAL

Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.

Drug: solifenacin succinate; Drug: tamsulosin hydrochloride

9 mg Solifenacin + 0.4 mg Tamsulosin

EXPERIMENTAL

Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.

Drug: solifenacin succinate; Drug: tamsulosin hydrochloride

Interventions

solifenacin succinate DRUG

Solifenacin succinate tablets

Also known as: YM905, VESIcare

6 mg Solifenacin + 0.4 mg Tamsulosin; 9 mg Solifenacin + 0.4 mg Tamsulosin

tamsulosin hydrochloride DRUG

Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets

Also known as: Omnic Ocas, Flomax CR

6 mg Solifenacin + 0.4 mg Tamsulosin; 9 mg Solifenacin + 0.4 mg Tamsulosin

Placebo to solifenacin DRUG

Placebo

Placebo to tamsulosin DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosed with Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
• BOO indication by a Bladder Outlet Obstruction Index (BOOI) ≥ 20
• Patient had a maximum urinary flow rate of ≤ 12 mL/sec, with a voided volume of ≥ 120 mL during free flow in a representative assessment of uroflowmetry.

You may not qualify if:

• History of urinary retention in preceding 12 months
• Current urinary tract infection (UTI) or symptomatic and recurrent UTI of \> 3 episodes within 12 months.
• Known clinical history or diagnosis of chronic inflammation, stone in bladder or ureter, or other causes of outflow tract obstruction
• Known diagnosis or history of carcinoma or previous pelvic radiation therapy, except non-metastatic basal or squamous cell carcinoma of the skin that had been treated successfully
• Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Visit 1

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (33)

Unknown Facility

Homewood, Alabama, 35209, United States

Location

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La Mesa, California, 91942, United States

Location

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Long Beach, California, 90806, United States

Location

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San Bernardino, California, 92404, United States

Location

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San Diego, California, 92108, United States

Location

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Middlebury, Connecticut, 06762, United States

Location

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New Port Richey, Florida, 34655, United States

Location

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Coeur d'Alene, Idaho, 83814, United States

Location

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Des Moines, Iowa, 50309, United States

Location

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Iowa City, Iowa, 52242, United States

Location

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Watertown, Massachusetts, 02472, United States

Location

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Las Vegas, Nevada, 89148, United States

Location

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New York, New York, 10021, United States

Location

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Greensboro, North Carolina, 27403, United States

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Austin, Texas, 78705, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Charlottesville, Virginia, 22908, United States

Location

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Edegem, 2650, Belgium

Location

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Kortrijk, Belgium

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Olomouc, Czechia

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Pilsen, Czechia

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Prague, Czechia

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Aachen, Germany

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Hagenow, Germany

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Landshut, Germany

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Mülheim, Germany

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Budapest, Hungary

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Szeged, Hungary

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Szekszárd, Hungary

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Bialystok, Poland

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Mysłowice, Poland

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Szczecin, Poland

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Unknown Facility

Warsaw, Poland

Location

Related Publications (1)

• Kaplan SA, He W, Koltun WD, Cummings J, Schneider T, Fakhoury A. Solifenacin plus tamsulosin combination treatment in men with lower urinary tract symptoms and bladder outlet obstruction: a randomized controlled trial. Eur Urol. 2013 Jan;63(1):158-65. doi: 10.1016/j.eururo.2012.07.003. Epub 2012 Jul 17.

  PMID: 22831853 RESULT

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Bladder Neck Obstruction

Interventions

Solifenacin Succinate; Tamsulosin

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

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

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: Senior Medical Director, Medical Affairs
• Organization: Astellas Pharma Global Development, Inc.

clinicaltrials@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: July 25, 2007
• First Posted: July 26, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 6, 2014
• Results First Posted: August 6, 2014

Record last verified: 2014-07

Locations

PL (4); CZ (3); BE (2); US (17); DE (4); HU (3)