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| Sponsor: | Astellas Pharma Inc |
|---|---|
| Information provided by: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00510406 |
Purpose
The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.
| Condition | Intervention | Phase |
|---|---|---|
|
Lower Urinary Tract Symptoms Prostatic Hyperplasia |
Drug: tamsulosin hydrochloride Drug: solifenacin succinate Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi Center Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy in Males With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) |
| Enrollment: | 919 |
| Study Start Date: | January 2007 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A: Placebo Comparator |
Drug: Placebo
Placebo
|
| B: Active Comparator |
Drug: solifenacin succinate
antimuscarinic
|
| C: Active Comparator |
Drug: solifenacin succinate
antimuscarinic
|
| D: Active Comparator |
Drug: solifenacin succinate
antimuscarinic
|
| E: Active Comparator |
Drug: tamsulosin hydrochloride
Alphablocker
|
| F: Active Comparator |
Drug: tamsulosin hydrochloride
Alphablocker
Drug: solifenacin succinate
antimuscarinic
|
| G: Active Comparator |
Drug: tamsulosin hydrochloride
Alphablocker
Drug: solifenacin succinate
antimuscarinic
|
| H: Active Comparator |
Drug: tamsulosin hydrochloride
Alphablocker
Drug: solifenacin succinate
antimuscarinic
|
Placebo Solifenacin succinate Tamsulosin hydrochloride Tamsulosin hydrochloride + solifenacin succinate
The primary comparison will be the combination treatment with tamsulosin hydrochloride monotherapy.
Other comparisons will be:
Placebo and combination treatment. Solifenacin monotherapy and combination treatment
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| Austria, North-West | |
| Linz, North-West, Austria | |
| Austria, Styria | |
| Graz, Styria, Austria | |
| Austria, Vienna | |
| Wien, Vienna, Austria | |
| Czech Republic | |
| Ostrava, Czech Republic | |
| Plzen, Czech Republic | |
| Prague, Czech Republic | |
| Usti nad Labem, Czech Republic | |
| Denmark | |
| Skejby, Denmark | |
| Aalborg, Denmark | |
| Frederiksberg, Denmark | |
| Roskilde, Denmark | |
| Finland | |
| Tampere, Finland | |
| Oulu, Finland | |
| Lahti, Finland | |
| Kuopio, Finland | |
| Helsinki, Finland | |
| France | |
| Paris, France | |
| Cote de Nacre, France | |
| Mulhouse, France | |
| Montlucon, France | |
| Creteil, France | |
| Ploemer, France | |
| Marseille, France | |
| Colmar, France | |
| Nimes, France | |
| Germany | |
| Hagenow, Germany | |
| Neustadt i. Sachsen, Germany | |
| Lutherstadt Eisleben, Germany | |
| Koblenz, Germany | |
| Dresden, Germany | |
| Munchen, Germany | |
| Henningsdorf, Germany | |
| Trier, Germany | |
| Hettstedt, Germany | |
| Ganderkessee, Germany | |
| Halle/Saale, Germany | |
| Bautzen, Germany | |
| Bamberg, Germany | |
| Münster, Germany | |
| Hamburg, Germany | |
| Uetersen, Germany | |
| Leipzig, Germany | |
| Bad Segeberg, Germany | |
| Hungary | |
| Sopron, Hungary | |
| Nyiregyháza, Hungary | |
| Tatabánya, Hungary | |
| Szeged, Hungary | |
| Miskolc, Hungary | |
| Budapest, Hungary | |
| Szekszárd, Hungary | |
| Eger, Hungary | |
| Netherlands | |
| Utrecht, Netherlands | |
| Netherlands, Friesland | |
| Sneek, Friesland, Netherlands | |
| Netherlands, Gelderland | |
| Nijmegen, Gelderland, Netherlands | |
| Netherlands, Limburg | |
| Maastricht, Limburg, Netherlands | |
| Netherlands, Noord-brabant | |
| Tilburg, Noord-brabant, Netherlands | |
| S'Hertogenbosch, Noord-brabant, Netherlands | |
| Netherlands, Noord-Holland | |
| Amsterdam, Noord-Holland, Netherlands | |
| Netherlands, Overijssel | |
| Apeldoorn, Overijssel, Netherlands | |
| Deventer, Overijssel, Netherlands | |
| Norway | |
| Tonsberg, Norway | |
| Fredrikstad, Norway | |
| Oslo, Norway | |
| Poland | |
| Lublin, Poland | |
| Bydgoszcz, Poland | |
| Cracow, Poland | |
| Katowice, Poland | |
| Lódz, Poland | |
| Szczecin, Poland | |
| Pulawy, Poland | |
| Bialystok, Poland | |
| Warszawa, Poland | |
| Portugal | |
| Tomar, Portugal | |
| Carmo, Portugal | |
| Santa Luzia, Portugal | |
| Pulido Valente, Portugal | |
| Amadora-Sintra, Portugal | |
| Coimbra (Covões), Portugal | |
| Orta EPE, Portugal | |
| Russian Federation | |
| St. Petersburg, Russian Federation | |
| Moscow, Russian Federation | |
| Slovakia | |
| Zilina, Slovakia | |
| Trencin, Slovakia | |
| Nitra, Slovakia | |
| Spain | |
| Sevilla, Spain | |
| La Coruna, Spain | |
| Barcelona, Spain | |
| Madrid, Spain | |
| Pontevedra, Spain | |
| Sweden | |
| Stockholm, Sweden | |
| Upsala, Sweden | |
| Kungälv, Sweden | |
| Uddevalla, Sweden | |
| Sundsvall, Sweden | |
| United Kingdom, Berkshire | |
| Reading, Berkshire, United Kingdom | |
| United Kingdom, Lancashire | |
| Chorley, Lancashire, United Kingdom | |
| United Kingdom, Wales | |
| Swansea, Wales, United Kingdom | |
| Cardiff, Wales, United Kingdom | |
| Study Director: | Central Contact | Astellas Pharma Europe BV |
More Information
| Responsible Party: | Astellas Pharma Europe BV ( Disclosure Office Europe ) |
| Study ID Numbers: | 905-CL-052, EudraCT number: 2006-002072-18 |
| Study First Received: | July 31, 2007 |
| Last Updated: | December 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00510406 History of Changes |
| Health Authority: | Austria: Federal Ministry for Health and Women; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; 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: Ministry of Health; Portugal: National Pharmacy and Medicines Institute; Slovakia: State Institute for Drug Control; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Norway: Norwegian Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation |
|
Lower Urinary Tract Symptoms Treatment Solifenacin succinate Tamsulosin hydrochloride Prostatic Hyperplasia |
|
Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Prostatic Diseases Adrenergic Agents Antineoplastic Agents Physiological Effects of Drugs Adrenergic alpha-Antagonists Cholinergic Agents Genital Diseases, Male |
Pharmacologic Actions Muscarinic Antagonists Hyperplasia Pathologic Processes Prostatic Hyperplasia Therapeutic Uses Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Tamsulosin Adrenergic Antagonists |
