Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00771394

Purpose

To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH) with tamsulosin hydrochloride for at least 6 weeks

Condition	Intervention	Phase
Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy Overactive Bladder	Drug: Tamsulosin hydrochloride Drug: Solifenacin succinate	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Solifenacin Succinate as Add-on Therapy for Overactive Bladder (OAB) Symptoms in Men Treated for Benign Prostatic Hyperplasia (BPH) With Tamsulosin Hydrochloride

Resource links provided by NLM:

Drug Information available for: Succinic acid Tamsulosin Tamsulosin hydrochloride Solifenacin succinate

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Change from baseline in mean number of urgency episodes per 24 hours [ Time Frame: at 4, 8, 12 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean number of micturitions per 24 hrs [ Time Frame: at 4, 8, 12 week ] [ Designated as safety issue: No ]
Mean number of incontinence episodes per 24 hours [ Time Frame: at 4, 8, 12 week ] [ Designated as safety issue: No ]
Mean number of micturitions per night [ Time Frame: at 4, 8, 12 week ] [ Designated as safety issue: No ]
Adverse Events, Laboratory Tests [ Time Frame: end of study ] [ Designated as safety issue: No ]

Enrollment:	638
Study Start Date:	October 2008
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1. Tamsulosin alone	Drug: Tamsulosin hydrochloride oral Other Names: Harnal YM617
Experimental: 2. Tamsulosin + solifenacin (low dose)	Drug: Tamsulosin hydrochloride oral Other Names: Harnal YM617 Drug: Solifenacin succinate oral Other Names: Vesicare YM905
Active Comparator: 3. Tamsulosin + solifenacin (high dose)	Drug: Tamsulosin hydrochloride oral Other Names: Harnal YM617 Drug: Solifenacin succinate oral Other Names: Vesicare YM905

Detailed Description:

Study drugs are administered for 14 weeks in total, including a 2-week run-in period (single blind) and a 12-week treatment period (double blind). After written informed consent, study drugs for the run-in period are orally administered once daily after breakfast for two weeks to subjects who fulfill the inclusion and exclusion criteria. Then, subjects are randomized and orally treated with study drugs for the treatment period once daily after breakfast for 12 weeks

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with benign prostatic hypertrophy who have been treated with tamsulosin for at least 6 weeks
Patients with urgency episodes and frequent micturitions
Written informed consent has been obtained
Uroflowmetry-Q max ≥ 5 mL/sec, and Post Void Residual Volume < 50 mL

Exclusion Criteria:

Patients with suspected symptoms of OAB whose onset is only transient (drug-induced, psychogenic, etc.)
Patients with obvious stress urinary incontinence
Patients with complications or who have a past history of a bladder tumor
Patients with urethral stricture or bladder neck stenosis
Patients with a history of surgery causing damage to the pelvic plexus
Patients with history of hypersensitivity to α receptor blockers, a/b receptor blockers, or anticholinergic drugs
Patients with orthostatic hypotension, ulcerative colitis, hyperthyroidism, dementia or cognitive dysfunction, Parkinson's disease, or cerebrovascular disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771394

Locations

Japan

Chubu, Japan

Chugoku, Japan

Hokkaido, Japan

Kansai, Japan

Kantou, Japan

Kyushu, Japan

Shikoku, Japan

Touhoku, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Central Contact

Astellas Pharma Inc

More Information

No publications provided

Responsible Party:	Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00771394 History of Changes
Other Study ID Numbers:	905-JC-001
Study First Received:	October 9, 2008
Last Updated:	March 3, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:

Vesicare
Solifenacin succinate
Tamsulosin
Overactive Bladder
BPH

Additional relevant MeSH terms:

Prostatic Hyperplasia
Hyperplasia
Hypertrophy
Urinary Bladder, Overactive
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Tamsulosin

Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 24, 2012