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62 Mechanisms of Action

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|||||||||| Trial completion date: Effect of Pelvic Floor and Hip Muscle Strengthening in the Treatment of Stress Urinary Incontinence (clinicaltrials.gov) - May 8, 2014
P=N/A, N=40, Recruiting, Sponsor: University of Sao Paulo General Hospital
Trial completion date: Jul 2014 --> Nov 2014

||||||||||  losmapimod (FTX-1821) / Fulcrum Therap
Trial initiation date:  A Phase II, Repeat Dose, Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients With Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) -  May 7, 2014
P2, N=24, Not yet recruiting,  Sponsor: GlaxoSmithKline
Trial completion date: Jul 2014 --> Nov 2014 Initiation date: Apr 2014 --> Jun 2014

||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
Enrollment closed:  Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA) (clinicaltrials.gov) -  May 5, 2014
P3, N=380, Active, not recruiting,  Sponsor: NICHD Pelvic Floor Disorders Network
Initiation date: Apr 2014 --> Jun 2014 Recruiting --> Active, not recruiting

|||||||||| New P4 trial: Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence (clinicaltrials.gov) - May 2, 2014
P4, N=200, Not yet recruiting, Sponsor: National Taiwan University Hospital

|||||||||| Trial primary completion date: One Year Outcome Using the Ajust System for Treatment of Urinary Stress Incontinence (clinicaltrials.gov) - Apr 30, 2014
P=N/A, N=500, Completed, Sponsor: Roskilde County Hospital
Recruiting --> Active, not recruiting Trial primary completion date: May 2013 --> Apr 2014

||||||||||  Vesicare (solifenacin) / Astellas
New P3 trial:  BryoSoliP: Bryophyllum Pinnatum Versus Solifenacin Versus Placebo for Overactive Bladder (clinicaltrials.gov) -  Apr 30, 2014
P3, N=30, Enrolling by invitation,  Sponsor: University of Zurich

|||||||||| Trial completion: One Year Outcome Using the Ajust System for Treatment of Urinary Stress Incontinence (clinicaltrials.gov) - Apr 30, 2014
P=N/A, N=500, Completed, Sponsor: Roskilde County Hospital
Trial primary completion date: May 2013 --> Apr 2014 Recruiting --> Completed

|||||||||| Clinical: POUR-RCT: When to Perform Bladder Catheterization in Fast-track Hip and Knee Arthroplasty (clinicaltrials.gov) - Apr 23, 2014
P=N/A, N=800, Not yet recruiting, Sponsor: Rigshospitalet, Denmark

|||||||||| New P1/2 trial: Changes in ALPP in Women With SUI Following Air Instillation (clinicaltrials.gov) - Apr 10, 2014
P1/2, N=6, Not yet recruiting, Sponsor: Meir Medical Center

|||||||||| Enrollment open: Muscle Progenitor Cell Therapy for Urinary Incontinence (clinicaltrials.gov) - Mar 30, 2014
P1/2, N=10, Recruiting, Sponsor: Gopal Badlani, MD
Recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  Vesicare (solifenacin) / Astellas
Trial completion:  Effectiveness and Safety Study of Solifenacin Succinate and Solifenacin Succinate + Estrogen to Treat OAB in Postmenopausal Women (clinicaltrials.gov) -  Mar 18, 2014
P4, N=200, Completed,  Sponsor: Peking Union Medical College Hospital
Not yet recruiting --> Recruiting Recruiting --> Completed

|||||||||| Enrollment change: HUPP: Hypertension and Urine Protease Activity in Preeclampsia (clinicaltrials.gov) - Mar 13, 2014
P=N/A, N=30, Recruiting, Sponsor: Odense University Hospital
Recruiting --> Completed N=40 --> 30

|||||||||| Clinical: The Efficacy of Pilates in the Recovery of Post-prostatectomy Urinary Incontinence (clinicaltrials.gov) - Mar 11, 2014
P=N/A, N=54, Completed, Sponsor: Universidade Estadual de Londrina

||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
Enrollment closed:  Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS) (clinicaltrials.gov) -  Mar 10, 2014
P3, N=185, Active, not recruiting,  Sponsor: Allergan
N=40 --> 30 Recruiting --> Active, not recruiting

|||||||||| Trial initiation date: Exercises for Urinary Incontinence(UI) of Women With Multiple Sclerosis (MS) (clinicaltrials.gov) - Feb 25, 2014
P=N/A, N=34, Not yet recruiting, Sponsor: Hadassah Medical Organization
Recruiting --> Active, not recruiting Initiation date: Jun 2013 --> Feb 2014

|||||||||| Enrollment change: Exercises for Urinary Incontinence(UI) of Women With Multiple Sclerosis (MS) (clinicaltrials.gov) - Feb 25, 2014
P=N/A, N=34, Not yet recruiting, Sponsor: Hadassah Medical Organization
Initiation date: Jun 2013 --> Feb 2014 N=130 --> 34

|||||||||| Enrollment closed: RAND: Albuminuria Reduction With Renin Angiotensin System Inhibitors in SCA Patients (clinicaltrials.gov) - Feb 25, 2014
P=N/A, N=53, Active, not recruiting, Sponsor: Assistance Publique - H
N=130 --> 34 Recruiting --> Active, not recruiting

||||||||||  Invokana (canagliflozin) / J&J, Daiichi Sankyo, Mitsubishi Tanabe
Enrollment open:  CANVAS-R: A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) -  Feb 23, 2014
P4, N=5700, Recruiting,  Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

|||||||||| Enrollment open: IEUF: Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence (clinicaltrials.gov) - Feb 23, 2014
P=N/A, N=50, Recruiting, Sponsor: Centre Hospitalier Universitaire de N?mes
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting

|||||||||| Trial completion: Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder (clinicaltrials.gov) - Feb 22, 2014
P4, N=395, Completed, Sponsor: Novartis
Not yet recruiting --> Recruiting No longer recruiting --> Completed

|||||||||| Trial completion: IRIS: Incontinence Research Intervention Study (clinicaltrials.gov) - Feb 22, 2014
P1/2, N=320, Completed, Sponsor: University of Michigan
No longer recruiting --> Completed Recruiting --> Completed

||||||||||  Soliris (eculizumab) / AstraZeneca
Trial completion:  Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients (clinicaltrials.gov) -  Feb 22, 2014
P3, N=75, Completed,  Sponsor: Alexion Pharmaceuticals
Recruiting --> Completed No longer recruiting --> Completed

||||||||||  Soliris (eculizumab) / AstraZeneca
Trial completion:  Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) (clinicaltrials.gov) -  Feb 22, 2014
P3, N=187, Completed,  Sponsor: Alexion Pharmaceuticals
No longer recruiting --> Completed No longer recruiting --> Completed

||||||||||  Soliris (eculizumab) / AstraZeneca
Trial completion:  Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab (clinicaltrials.gov) -  Feb 22, 2014
P3, N=85, Completed,  Sponsor: Alexion Pharmaceuticals
No longer recruiting --> Completed No longer recruiting --> Completed

|||||||||| Trial completion: Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence (clinicaltrials.gov) - Feb 22, 2014
P2/3, N=221, Completed, Sponsor: Uromedica
No longer recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Soliris (eculizumab) / AstraZeneca
Trial completion:  Eculizumab in Treating Patients With Paroxysmal Nocturnal Hemoglobinuria (clinicaltrials.gov) -  Feb 22, 2014
P3, N=0, Completed,  Sponsor: Jonsson Comprehensive Cancer Center
Active, not recruiting --> Completed Recruiting --> Completed

||||||||||  Soliris (eculizumab) / AstraZeneca
Trial completion:  Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria (clinicaltrials.gov) -  Feb 22, 2014
P3, N=75, Completed,  Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Recruiting --> Completed No longer recruiting --> Completed

||||||||||  ramipril / Generic mfg., irbesartan / Generic mfg.
Trial completion:  Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria (clinicaltrials.gov) -  Feb 22, 2014
P4, N=400, Completed,  Sponsor: Bristol-Myers Squibb
No longer recruiting --> Completed No longer recruiting --> Completed

||||||||||  tolterodine / Generic mfg.
Trial completion:  Behavior Enhances Drug Reduction of Incontinence (BE-DRI) (clinicaltrials.gov) -  Feb 22, 2014
P=N/A, N=307, Completed,  Sponsor: New England Research Institutes
No longer recruiting --> Completed No longer recruiting --> Completed

|||||||||| Trial completion: Colpopexy and Urinary Reduction Efforts (CARE) Protocol (clinicaltrials.gov) - Feb 22, 2014
P3, N=322, Completed, Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
No longer recruiting --> Completed No longer recruiting --> Completed

|||||||||| Trial completion: SISTEr: Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence (clinicaltrials.gov) - Feb 22, 2014
P2/3, N=655, Completed, Sponsor: New England Research Institutes
No longer recruiting --> Completed No longer recruiting --> Completed

||||||||||  emapticap pegol (NOX E36) / TME Pharma
Trial completion:  NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria (clinicaltrials.gov) -  Feb 20, 2014
P2a, N=76, Completed,  Sponsor: NOXXON Pharma AG
No longer recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Leukine (sargramostim) / Partner Therap
Trial completion:  Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer (clinicaltrials.gov) -  Feb 19, 2014
P1, N=35, Completed,  Sponsor: National Cancer Institute (NCI)
Active, not recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Trial completion: VADUS: 3D Ultrasound in Women With Vacuum or Forceps Deliveries (clinicaltrials.gov) - Feb 18, 2014
P=N/A, N=45, Completed, Sponsor: University of Rochester
Active, not recruiting --> Completed Recruiting --> Completed

||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
Enrollment open:  Evaluation of Safety and Efficacy of Botulinum Toxin Type A (BOTOX (clinicaltrials.gov) -  Feb 9, 2014
P=N/A, N=600, Recruiting,  Sponsor: Allergan
Recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  finasteride / Generic mfg.
Trial termination, Biopsy:  The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy (clinicaltrials.gov) -  Jan 28, 2014
P2, N=29, Terminated,  Sponsor: University of British Columbia
Not yet recruiting --> Recruiting Recruiting --> Terminated; Did not achieve enrollment goal and decided to terminate early

||||||||||  finasteride / Generic mfg.
Enrollment change, Biopsy:  The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy (clinicaltrials.gov) -  Jan 28, 2014
P2, N=29, Terminated,  Sponsor: University of British Columbia
Recruiting --> Terminated; Did not achieve enrollment goal and decided to terminate early N=50 --> 29

||||||||||  Januvia (sitagliptin) / Merck (MSD)
New P4 trial:  Use of Sitagliptin to Decrease Microalbuminuria (clinicaltrials.gov) -  Jan 27, 2014
P4, N=110, Recruiting,  Sponsor: University of Missouri-Columbia

|||||||||| Enrollment open: Vitamin D Supplementation in Older Adults With Urinary Incontinence (clinicaltrials.gov) - Jan 14, 2014
P2/3, N=100, Recruiting, Sponsor: University of Alabama at Birmingham
N=50 --> 29 Not yet recruiting --> Recruiting

|||||||||| Enrollment closed: SOLECT: Solace European Confirmatory Trial (clinicaltrials.gov) - Jan 6, 2014
P=N/A, N=60, Active, not recruiting, Sponsor: Solace Therapeutics, Inc.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting

||||||||||  Selzentry (maraviroc) / ViiV Healthcare
Enrollment closed:  MARCHrenal: MARCH Renal Substudy (clinicaltrials.gov) -  Dec 16, 2013
P4, N=150, Active, not recruiting,  Sponsor: Kirby Institute
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting

|||||||||| Enrollment change: Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling (clinicaltrials.gov) - Dec 11, 2013
P=N/A, N=150, Active, not recruiting, Sponsor: Cook
Recruiting --> Active, not recruiting N=280 --> 150

|||||||||| Enrollment closed: Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling (clinicaltrials.gov) - Dec 11, 2013
P=N/A, N=150, Active, not recruiting, Sponsor: Cook
N=280 --> 150 Recruiting --> Active, not recruiting

|||||||||| Trial completion: TOMUS-Trial Of Mid-Urethral Slings (clinicaltrials.gov) - Dec 11, 2013
P4, N=597, Completed, Sponsor: New England Research Institutes
Recruiting --> Active, not recruiting Active, not recruiting --> Completed

||||||||||  setanaxib (GKT831) / Calliditas
New P2 trial:  Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria (clinicaltrials.gov) -  Dec 10, 2013
P2, N=200, Recruiting,  Sponsor: Genkyotex Innovation SAS

|||||||||| Trial completion: ICASH: Impedance Cardiographic (ICG) Assessment of Pregnant Women With Severe Hypertension to Assess Impact of Standard Therapy (clinicaltrials.gov) - Dec 10, 2013
P=N/A, N=30, Completed, Sponsor: University of Mississippi Medical Center
Active, not recruiting --> Completed Recruiting --> Completed

||||||||||  sunitinib / Generic mfg.
Trial termination, Metastases:  Pharmacodynamic Effects of Anti-Vascular Endothelial Growth Factor Therapy in Patients With Advanced Malignancies (clinicaltrials.gov) -  Dec 9, 2013
P=N/A, N=0, Terminated,  Sponsor: National University Hospital, Singapore
Recruiting --> Completed Recruiting --> Terminated

|||||||||| Trial initiation date: IEUF: Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence (clinicaltrials.gov) - Dec 8, 2013
P=N/A, N=50, Recruiting, Sponsor: Centre Hospitalier Universitaire de N?mes
Recruiting --> Terminated Initiation date: Sep 2013 --> Feb 2014

||||||||||  losmapimod (FTX-1821) / Fulcrum Therap
New P2 trial:  A Phase II, Repeat Dose, Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients With Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) -  Dec 2, 2013
P2, N=24, Not yet recruiting,  Sponsor: GlaxoSmithKline

|||||||||| Enrollment open: Efficacy of Magnetic Stimulation for Stress Urinary Incontinence (clinicaltrials.gov) - Dec 2, 2013
P=N/A, N=120, Recruiting, Sponsor: QRS Asia Sdn Bhd
Initiation date: Sep 2013 --> Feb 2014 Not yet recruiting --> Recruiting