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Solifenacin

Generic Name
Solifenacin
Brand Names
Vesicare
Drug Type
Small Molecule
Chemical Formula
C23H26N2O2
CAS Number
242478-37-1
Unique Ingredient Identifier
A8910SQJ1U
Background

Solifenacin is a competitive muscarinic receptor antagonist indicated to treat an overactive bladder with urinary incontinence, urgency, and frequency. It has a long duration of action as it is usually taken once daily.

Solifenacin was granted FDA approval on 19 November 2004.

Indication

Solifenacin tablets are indicated to treat an overactive bladder with urinary incontinence, urgency, and frequency.

Associated Conditions
Benign Prostatic Hyperplasia (BPH), Overactive Bladder Syndrome (OABS)

A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

Phase 3
Completed
Conditions
Overactive Bladder
Urinary Bladder Overactive
Urgency Incontinence
Urinary Bladder Diseases\Urologic Diseases
Interventions
First Posted Date
2014-01-27
Last Posted Date
2024-10-31
Lead Sponsor
Astellas Pharma Europe B.V.
Target Recruit Count
1829
Registration Number
NCT02045862
Locations
🇺🇸

Site US10133, Los Angeles, California, United States

🇺🇸

Site US10553, Lincoln, Nebraska, United States

🇺🇸

Site US10148, Hialeah, Florida, United States

and more 248 locations

A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels

Phase 1
Completed
Conditions
Phase 1
Bioavailability
Healthy Subjects
Interventions
First Posted Date
2013-12-13
Last Posted Date
2013-12-13
Lead Sponsor
Astellas Pharma Europe B.V.
Target Recruit Count
72
Registration Number
NCT02010944
Locations
🇩🇪

Parexel, Berlin, Germany

A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)

Phase 3
Completed
Conditions
Neurogenic Detrusor Overactivity
Pediatric
Interventions
First Posted Date
2013-11-13
Last Posted Date
2024-10-31
Lead Sponsor
Astellas Pharma Europe B.V.
Target Recruit Count
23
Registration Number
NCT01981954
Locations
🇰🇷

Site KR8201 Severance Hospital, Seoul, Korea, Republic of

🇵🇭

Site PH6301 Philippines Children's Medical Center, Manila, Philippines

🇺🇸

Site US1008 Pediatric Urology Associates, P.C., Tarrytown, New York, United States

and more 5 locations

This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

Phase 3
Completed
Conditions
Urinary Bladder Overactive
Urinary Bladder Diseases\Urologic Diseases
Overactive Bladder
Urgency Incontinence
Interventions
First Posted Date
2013-10-31
Last Posted Date
2024-10-31
Lead Sponsor
Astellas Pharma Europe B.V.
Target Recruit Count
3527
Registration Number
NCT01972841
Locations
🇩🇪

Site DE49034 LMU Muenchen, Munich, Germany

🇩🇪

Site DE49001 Private Practice, Neustadt I. Sachsen, Germany

🇺🇸

Site US10064 The Group for Women, Virginia Beach, Virginia, United States

and more 432 locations

A Study to Compare the Amount of Drug in the Blood After a Single Tablet EC905 Containing Solifenacin and Tamsulosin is Taken by Healthy Males Compared to Separate Tablets of Solifenacin and Tamsulosin

Phase 1
Completed
Conditions
EC905
Pharmacokinetics
Healthy Subjects
Interventions
First Posted Date
2013-10-01
Last Posted Date
2014-05-29
Lead Sponsor
Astellas Pharma Europe B.V.
Target Recruit Count
30
Registration Number
NCT01953887
Locations
🇬🇧

Parexel, London, United Kingdom

A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)

First Posted Date
2013-07-26
Last Posted Date
2024-10-31
Lead Sponsor
Astellas Pharma Europe Ltd.
Target Recruit Count
2174
Registration Number
NCT01908829
Locations
🇺🇸

Urology Center of Central Florida, Kissimmee, Florida, United States

🇺🇸

Alliance Urology Specialists, Greensboro, North Carolina, United States

🇳🇴

Site: 47005, Bekkestua, Norway

and more 214 locations

Comparison of Tamsulosin and Solifenacin in Treatment of Ureteral Stent Symptoms

Phase 4
Completed
Conditions
Relieve of Ureteral Stent Symptoms
Interventions
First Posted Date
2013-06-19
Last Posted Date
2015-11-25
Lead Sponsor
Mansoura University
Target Recruit Count
131
Registration Number
NCT01880619
Locations
🇪🇬

Urology and Nephrology Center, Mansoura, Egypt

Comparisons of 3-month Versus 6-month Solifenacin Treatment for Female OAB Patients

Phase 4
Conditions
Overactive Bladder Syndrome
Interventions
First Posted Date
2013-06-12
Last Posted Date
2015-07-07
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
200
Registration Number
NCT01876186
Locations
🇨🇳

Department of Obstetrics & Gynecology, National Taiwan University Hospital, Taipei, Taiwan

Effectiveness and Safety Study of Solifenacin Succinate and Solifenacin Succinate + Estrogen to Treat OAB in Postmenopausal Women

Phase 4
Completed
Conditions
Overactive Bladder
Postmenopausal Disorder
Urination Disorders
Interventions
First Posted Date
2013-04-17
Last Posted Date
2014-03-20
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
200
Registration Number
NCT01833663
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, Beijing, China

Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome)

Completed
Conditions
Lower Urinary Tract Predominant Storage Symptoms
Interventions
First Posted Date
2013-02-27
Last Posted Date
2013-12-19
Lead Sponsor
Astellas Pharma Europe B.V.
Target Recruit Count
86
Registration Number
NCT01799902
Locations
🇧🇪

H.Hart Roeselaere, Roeselaere, Belgium

🇧🇪

Maria Middelares, Gent, Belgium

🇧🇪

AZ Damiaan, Oostende, Belgium

and more 12 locations
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