Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms (Neptune II)
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01021332
First received: November 24, 2009
Last updated: February 2, 2012
Last verified: February 2012
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Purpose
Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.
| Condition | Intervention | Phase |
|---|---|---|
|
Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia |
Drug: tamsulosin hydrochloride/solifenacin succinate combination |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 gm and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component |
Resource links provided by NLM:
MedlinePlus related topics:
Urine and Urination
Drug Information available for:
Succinic acid
Tamsulosin
Tamsulosin hydrochloride
Solifenacin succinate
U.S. FDA Resources
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Safety variables: Incidence, severity and relationship of AEs to the study drug, Vital signs, ECG parameters, Laboratory parameters, Physical examination, PVR volume, Qmax and Qmean [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline to endpoint in data from micturition diary, I-PSS questionnaire [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 1067 |
| Study Start Date: | April 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1. tamsulosin/solifenacin combi, low dose |
Drug: tamsulosin hydrochloride/solifenacin succinate combination
oral
Other Name: EC905
|
| Experimental: 2. tamsulosin/solifenacin combi, high dose |
Drug: tamsulosin hydrochloride/solifenacin succinate combination
oral
Other Name: EC905
|
Detailed Description:
This is an open-label extension study following the double blind 905-CL-055 study
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Completion of 12 weeks double-blind treatment in Study 905-CL-055
Exclusion Criteria:
- Any significant PVR volume (>150 mL)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021332
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Hide Study LocationsLocations
| Austria | |
| Innsbruck, Austria, 6020 | |
| Vienna, Austria, 1090 | |
| Belarus | |
| Minsk, Belarus, 220036 | |
| Minsk, Belarus, 220119 | |
| Minsk, Belarus, 223040 | |
| Belgium | |
| Antwerp, Belgium, 2020 | |
| Edegem, Belgium, 2650 | |
| Gent, Belgium, 9000 | |
| Leuven, Belgium, 3000 | |
| Liege 1, Belgium, 4000 | |
| Czech Republic | |
| Hradec Kralove, Czech Republic, 500 02 | |
| Ostrava, Czech Republic, 700 30 | |
| Plzen, Czech Republic, 301 24 | |
| Roudnice nad Labem, Czech Republic, 413 01 | |
| Uherske Hradiste, Czech Republic, 686 08 | |
| Usti nad Labem, Czech Republic, 400 01 | |
| Zd'ar nad Sazavou, Czech Republic, 591 01 | |
| France | |
| Colmar Cedex, France, 68024 | |
| Montlucon, France, 03100 | |
| Orleans cedex 2, France, 45067 | |
| Paris, France, 75010 | |
| Paris Cedex 10, France, 75020 | |
| Pierre Benite, France, 69495 | |
| Germany | |
| Bautzen, Germany, 02625 | |
| Frankfurt, Germany, 65933 | |
| Ganderkesee, Germany, 27777 | |
| Hagenow, Germany, 19230 | |
| Halle Saale, Germany, 06132 | |
| Hamburg, Germany, 20253 | |
| Henningsdorf, Germany, 16761 | |
| Hettstedt, Germany, 06333 | |
| Koblenz, Germany, 56068 | |
| Leipzig, Germany, 04105 | |
| Leipzig, Germany, 04109 | |
| Lutherstadt Eisleben, Germany, 06295 | |
| Neustadt in Sachsen, Germany, 01844 | |
| Radebeul, Germany, 01445 | |
| Sachsen, Germany, 06526 | |
| Trier, Germany, 54290 | |
| Uetersen, Germany, 25436 | |
| Italy | |
| Avellino, Italy, 83100 | |
| Catanzaro, Italy, 88100 | |
| Palermo, Italy, 90146 | |
| Treviglio, Italy, 24047 | |
| Netherlands | |
| Amsterdam, Netherlands, 100 AD | |
| Apeldoorn, Netherlands, 7334 DZ | |
| Doetinchem, Netherlands, 7009 BL | |
| Maastricht, Netherlands, 6229 HX | |
| Sneek, Netherlands, 8600 BA | |
| Tilburg, Netherlands, 5022 GC | |
| Winterswijk, Netherlands, 7101 BN | |
| Poland | |
| Bielsko-Biala, Poland, 43-300 | |
| Bydgoszcz, Poland, 85-094 | |
| Krakow, Poland, 31-530 | |
| Pulawy, Poland, 24-100 | |
| Warsaw, Poland, 02-005 | |
| Wiecbork, Poland, 89-410 | |
| Slovakia | |
| Nitra, Slovakia, 949 01 | |
| Piestany, Slovakia, 921 02 | |
| Presov, Slovakia, 080 01 | |
| Skalica, Slovakia, 909 82 | |
| Trencin, Slovakia, 911 01 | |
| United Kingdom | |
| Cardiff, United Kingdom, CF14 5GJ | |
| Chorley, United Kingdom, PR7 7NA | |
| Liverpool, United Kingdom, L22 0LG | |
| Northwood, United Kingdom, HA6 2RN | |
| Oxford, United Kingdom, OX3 7LJ | |
| Reading, United Kingdom, RG2 7AG | |
| Sheffield, United Kingdom, S10 2JF | |
| Taunton, United Kingdom, TA1 5DA | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Chair: | Use Central Contact | Astellas Pharma Global Development |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT01021332 History of Changes |
| Other Study ID Numbers: | 905-CL-057, 2008-001212-20 |
| Study First Received: | November 24, 2009 |
| Last Updated: | February 2, 2012 |
| Health Authority: | Austria: Federal Office for Safety in Health Care Belarus: Ministry of Health Belgium: Federal Agency for Medicinal Products and Health Products Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Italy: Ethics Committee Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation Slovakia: State Institute for Drug Control United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Astellas Pharma Inc:
|
Lower Urinary Tract Symptoms Treatment Solifenacin succinate Tamsulosin hydrochloride OCAS Benign Prostatic Hyperplasia |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Prostatic Diseases Genital Diseases, Male Pathologic Processes 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 May 23, 2013