Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2006-002072-18 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator |
| |
| B | Active Comparator |
| |
| C | Active Comparator |
| |
| D | Active Comparator |
| |
| E | Active Comparator |
| |
| F | Active Comparator |
| |
| G | Active Comparator |
| |
| H |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tamsulosin hydrochloride | Drug | Alphablocker |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assess whether the combination of solifenacin succinate and tamsulosin hydrochloride provides improved efficacy compared to tamsulosin hydrochloride alone in males with LUTS associated with BPH | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride | 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linz | North-West | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23537687 | Derived | Van Kerrebroeck P, Haab F, Angulo JC, Vik V, Katona F, Garcia-Hernandez A, Klaver M, Traudtner K, Oelke M. Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN). Eur Urol. 2013 Sep;64(3):398-407. doi: 10.1016/j.eururo.2013.03.031. Epub 2013 Mar 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| solifenacin succinate |
| Drug |
antimuscarinic |
|
| Placebo | Drug | Placebo |
|
| Vienna |
| State of Vienna |
| Austria |
| Graz | Styria | Austria |
| Ostrava | Czechia |
| Pilsen | Czechia |
| Prague | Czechia |
| Ústí nad Labem | Czechia |
| Aalborg | Denmark |
| Frederiksberg | Denmark |
| Roskilde | Denmark |
| Skejby | Denmark |
| Helsinki | Finland |
| Kuopio | Finland |
| Lahti | Finland |
| Oulu | Finland |
| Tampere | Finland |
| Colmar | France |
| Cote de Nacre | France |
| Créteil | France |
| Marseille | France |
| Montluçon | France |
| Mulhouse | France |
| Nîmes | France |
| Paris | France |
| Ploemeur | France |
| Bad Segeberg | Germany |
| Bamberg | Germany |
| Bautzen | Germany |
| Dresden | Germany |
| Eisleben Lutherstadt | Germany |
| Ganderkessee | Germany |
| Hagenow | Germany |
| Halle | Germany |
| Hamburg | Germany |
| Henningsdorf | Germany |
| Hettstedt | Germany |
| Koblenz | Germany |
| Leipzig | Germany |
| München | Germany |
| Münster | Germany |
| Neustadt in Sachsen | Germany |
| Trier | Germany |
| Uetersen | Germany |
| Budapest | Hungary |
| Eger | Hungary |
| Miskolc | Hungary |
| Nyiregyháza | Hungary |
| Sopron | Hungary |
| Szeged | Hungary |
| Szekszárd | Hungary |
| Tatabánya | Hungary |
| Nijmegen | Gelderland | Netherlands |
| Maastricht | Limburg | Netherlands |
| S'Hertogenbosch | North Brabant | Netherlands |
| Tilburg | North Brabant | Netherlands |
| Amsterdam | North Holland | Netherlands |
| Apeldoorn | Overijssel | Netherlands |
| Deventer | Overijssel | Netherlands |
| Sneek | Provincie Friesland | Netherlands |
| Utrecht | Utrecht | Netherlands |
| Fredrikstad | Norway |
| Oslo | Norway |
| Tønsberg | Norway |
| Bialystok | Poland |
| Bydgoszcz | Poland |
| Cracow | Poland |
| Katowice | Poland |
| Lódz | Poland |
| Lublin | Poland |
| Puławy | Poland |
| Szczecin | Poland |
| Warsaw | Poland |
| Amadora-Sintra | Portugal |
| Carmo | Portugal |
| Coimbra (Covões) | Portugal |
| Orta EPE | Portugal |
| Pulido Valente | Portugal |
| Santa Luzia | Portugal |
| Tomar | Portugal |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Nitra | Slovakia |
| Trenčín | Slovakia |
| Žilina | Slovakia |
| A Coruña | Spain |
| Barcelona | Spain |
| Madrid | Spain |
| Pontevedra | Spain |
| Seville | Spain |
| Kungälv | Sweden |
| Stockholm | Sweden |
| Sundsvall | Sweden |
| Uddevalla | Sweden |
| Uppsala | Sweden |
| Reading | Berkshire | United Kingdom |
| Chorley | Lancashire | United Kingdom |
| Cardiff | Wales | United Kingdom |
| Swansea | Wales | United Kingdom |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided