Of note, >>[p]atients with orthostatic hypotension, ulcerative colitis, hyperthyroidism, dementia or cognitive dysfunction, Parkinson’s disease, or cerebrovascular disorder<< were excluded. How many real-life patients with BPH also have one of the above?
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Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00771394
First received: October 9, 2008
Last updated: March 3, 2010
Last verified: March 2010
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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:
|
| Experimental: 2. Tamsulosin + solifenacin (low dose) | Drug: Tamsulosin hydrochloride
oral
Other Names:
Drug: Solifenacin succinate oral
Other Names:
|
| Active Comparator: 3. Tamsulosin + solifenacin (high dose) | Drug: Tamsulosin hydrochloride
oral
Other Names:
Drug: Solifenacin succinate oral
Other Names:
|
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 September 30, 2012
