Back to resultsA Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH (SATURN)
Primary Purpose
Lower Urinary Tract Symptoms, Prostatic Hyperplasia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
tamsulosin hydrochloride
solifenacin succinate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lower Urinary Tract Symptoms focused on measuring Lower Urinary Tract Symptoms, Treatment, Solifenacin succinate, Tamsulosin hydrochloride, Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- male patients with LUTS associated with BPH diagnosed > 3 months
- IPSS score > 13
- voiding and storage symptoms
- maximum flow rate of > 4 mL/s and < 15 mL/s
Exclusion Criteria:
- post void residual volume > 200 mL
- symptomatic urinary tract infection
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
A
B
C
D
E
F
G
H
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00510406
Brief Title
A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH
Acronym
SATURN
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms, Prostatic Hyperplasia
Keywords
Lower Urinary Tract Symptoms, Treatment, Solifenacin succinate, Tamsulosin hydrochloride, Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
919 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Title
B
Arm Type
Active Comparator
Arm Title
C
Arm Type
Active Comparator
Arm Title
D
Arm Type
Active Comparator
Arm Title
E
Arm Type
Active Comparator
Arm Title
F
Arm Type
Active Comparator
Arm Title
G
Arm Type
Active Comparator
Arm Title
H
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
tamsulosin hydrochloride
Intervention Description
Alphablocker
Intervention Type
Drug
Intervention Name(s)
solifenacin succinate
Intervention Description
antimuscarinic
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male patients with LUTS associated with BPH diagnosed > 3 months
IPSS score > 13
voiding and storage symptoms
maximum flow rate of > 4 mL/s and < 15 mL/s
Exclusion Criteria:
post void residual volume > 200 mL
symptomatic urinary tract infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
City
Linz
State/Province
North-West
Country
Austria
City
Graz
State/Province
Styria
Country
Austria
City
Wien
State/Province
Vienna
Country
Austria
City
Ostrava
Country
Czech Republic
City
Plzen
Country
Czech Republic
City
Prague
Country
Czech Republic
City
Usti nad Labem
Country
Czech Republic
City
Aalborg
Country
Denmark
City
Frederiksberg
Country
Denmark
City
Roskilde
Country
Denmark
City
Skejby
Country
Denmark
City
Helsinki
Country
Finland
City
Kuopio
Country
Finland
City
Lahti
Country
Finland
City
Oulu
Country
Finland
City
Tampere
Country
Finland
City
Colmar
Country
France
City
Cote de Nacre
Country
France
City
Creteil
Country
France
City
Marseille
Country
France
City
Montlucon
Country
France
City
Mulhouse
Country
France
City
Nimes
Country
France
City
Paris
Country
France
City
Ploemer
Country
France
City
Bad Segeberg
Country
Germany
City
Bamberg
Country
Germany
City
Bautzen
Country
Germany
City
Dresden
Country
Germany
City
Ganderkessee
Country
Germany
City
Hagenow
Country
Germany
City
Halle/Saale
Country
Germany
City
Hamburg
Country
Germany
City
Henningsdorf
Country
Germany
City
Hettstedt
Country
Germany
City
Koblenz
Country
Germany
City
Leipzig
Country
Germany
City
Lutherstadt Eisleben
Country
Germany
City
Munchen
Country
Germany
City
Münster
Country
Germany
City
Neustadt i. Sachsen
Country
Germany
City
Trier
Country
Germany
City
Uetersen
Country
Germany
City
Budapest
Country
Hungary
City
Eger
Country
Hungary
City
Miskolc
Country
Hungary
City
Nyiregyháza
Country
Hungary
City
Sopron
Country
Hungary
City
Szeged
Country
Hungary
City
Szekszárd
Country
Hungary
City
Tatabánya
Country
Hungary
City
Sneek
State/Province
Friesland
Country
Netherlands
City
Nijmegen
State/Province
Gelderland
Country
Netherlands
City
Maastricht
State/Province
Limburg
Country
Netherlands
City
S'Hertogenbosch
State/Province
Noord-brabant
Country
Netherlands
City
Tilburg
State/Province
Noord-brabant
Country
Netherlands
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
City
Apeldoorn
State/Province
Overijssel
Country
Netherlands
City
Deventer
State/Province
Overijssel
Country
Netherlands
City
Utrecht
Country
Netherlands
City
Fredrikstad
Country
Norway
City
Oslo
Country
Norway
City
Tonsberg
Country
Norway
City
Bialystok
Country
Poland
City
Bydgoszcz
Country
Poland
City
Cracow
Country
Poland
City
Katowice
Country
Poland
City
Lublin
Country
Poland
City
Lódz
Country
Poland
City
Pulawy
Country
Poland
City
Szczecin
Country
Poland
City
Warszawa
Country
Poland
City
Amadora-Sintra
Country
Portugal
City
Carmo
Country
Portugal
City
Coimbra (Covões)
Country
Portugal
City
Orta EPE
Country
Portugal
City
Pulido Valente
Country
Portugal
City
Santa Luzia
Country
Portugal
City
Tomar
Country
Portugal
City
Moscow
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Nitra
Country
Slovakia
City
Trencin
Country
Slovakia
City
Zilina
Country
Slovakia
City
Barcelona
Country
Spain
City
La Coruna
Country
Spain
City
Madrid
Country
Spain
City
Pontevedra
Country
Spain
City
Sevilla
Country
Spain
City
Kungälv
Country
Sweden
City
Stockholm
Country
Sweden
City
Sundsvall
Country
Sweden
City
Uddevalla
Country
Sweden
City
Upsala
Country
Sweden
City
Reading
State/Province
Berkshire
Country
United Kingdom
City
Chorley
State/Province
Lancashire
Country
United Kingdom
City
Cardiff
State/Province
Wales
Country
United Kingdom
City
Swansea
State/Province
Wales
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23537687
Citation
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.
Results Reference
derived
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140531 in the JapicCTI-RNo. field
Learn more about this trial
A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH
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