NCT00771394

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
638

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

1.3 years

First QC Date

October 9, 2008

Last Update Submit

February 13, 2013

Conditions

Benign Prostatic HyperplasiaBenign Prostatic HypertrophyOveractive Bladder

Keywords

VesicareSolifenacin succinateTamsulosinOveractive BladderBPH

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in mean number of urgency episodes per 24 hours

    at 4, 8, 12 week

Secondary Outcomes (4)

  • Mean number of micturitions per 24 hrs

    at 4, 8, 12 week

  • Mean number of incontinence episodes per 24 hours

    at 4, 8, 12 week

  • Mean number of micturitions per night

    at 4, 8, 12 week

  • Adverse Events, Laboratory Tests

    end of study

Study Arms (3)

1. Tamsulosin alone

PLACEBO COMPARATOR
Drug: Tamsulosin hydrochloride

2. Tamsulosin + solifenacin (low dose)

EXPERIMENTAL
Drug: Tamsulosin hydrochlorideDrug: Solifenacin succinate

3. Tamsulosin + solifenacin (high dose)

ACTIVE COMPARATOR
Drug: Tamsulosin hydrochlorideDrug: Solifenacin succinate

Interventions

Tamsulosin hydrochlorideDRUG

oral

Also known as: Harnal, YM617
1. Tamsulosin alone2. Tamsulosin + solifenacin (low dose)3. Tamsulosin + solifenacin (high dose)
Solifenacin succinateDRUG

oral

Also known as: Vesicare, YM905
2. Tamsulosin + solifenacin (low dose)3. Tamsulosin + solifenacin (high dose)

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

MeSH Terms

Conditions

Prostatic HyperplasiaUrinary Bladder, Overactive

Interventions

TamsulosinSolifenacin Succinate

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsQuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 13, 2008

Study Start

October 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

JP(8)