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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00771394
First received: October 9, 2008
Last updated: February 13, 2013
Last verified: February 2013
  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:


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
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: 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

Additional Information:
No publications provided

Responsible Party: 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: February 13, 2013
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:
Hyperplasia
Hypertrophy
Prostatic Hyperplasia
Urinary Bladder, Overactive
Genital Diseases, Male
Lower Urinary Tract Symptoms
Pathologic Processes
Pathological Conditions, Anatomical
Prostatic Diseases
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Solifenacin
Tamsulosin
Adrenergic Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
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