Lower Urinary Tract SymptomsPhase 2SATURNNCT00510406
A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH
A Phase 2 study testing tamsulosin hydrochloride and solifenacin succinate in people with Lower Urinary Tract Symptoms and Prostatic Hyperplasia, run by Astellas Pharma Inc at 98 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia
- What is being tested?
- tamsulosin hydrochloride and solifenacin succinate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 919 participants
- Where
- 98 sitesin 16 countries
- Study dates
- Jan 2007to Sep 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- post void residual volume > 200 mL
- symptomatic urinary tract infection
Trial locations and contacts
98 sites in 16 countries.
98 sites in 16 countries
Germany18 sites
Study site
Bad Segeberg
Study site
Bamberg
Study site
Bautzen
Study site
Dresden
Study site
Eisleben Lutherstadt
Study site
Ganderkessee
Study site
Hagenow
Study site
Halle
Study site
Hamburg
Study site
Henningsdorf
Study site
Hettstedt
Study site
Koblenz
Study site
Leipzig
Study site
München
Study site
Münster
Study site
Neustadt in Sachsen
Study site
Trier
Study site
Uetersen
France9 sites
Study site
Colmar
Study site
Cote de Nacre
Study site
Créteil
Study site
Marseille
Study site
Montluçon
Study site
Mulhouse
Study site
Nîmes
Study site
Paris
Study site
Ploemeur
Netherlands9 sites
Study site
Amsterdam, North Holland
Study site
Apeldoorn, Overijssel
Study site
Deventer, Overijssel
Study site
Maastricht, Limburg
Study site
Nijmegen, Gelderland
Study site
S'Hertogenbosch, North Brabant
Study site
Sneek, Provincie Friesland
Study site
Tilburg, North Brabant
Study site
Utrecht, Utrecht
Poland9 sites
Study site
Bialystok
Study site
Bydgoszcz
Study site
Cracow
Study site
Katowice
Study site
Lódz
Study site
Lublin
Study site
Puławy
Study site
Szczecin
Study site
Warsaw
Hungary8 sites
Study site
Budapest
Study site
Eger
Study site
Miskolc
Study site
Nyiregyháza
Study site
Sopron
Study site
Szeged
Study site
Szekszárd
Study site
Tatabánya
Portugal7 sites
Study site
Amadora-Sintra
Study site
Carmo
Study site
Coimbra (Covões)
Study site
Orta EPE
Study site
Pulido Valente
Study site
Santa Luzia
Study site
Tomar
Finland5 sites
Study site
Helsinki
Study site
Kuopio
Study site
Lahti
Study site
Oulu
Study site
Tampere
Spain5 sites
Study site
A Coruña
Study site
Barcelona
Study site
Madrid
Study site
Pontevedra
Study site
Seville
Sweden5 sites
Study site
Kungälv
Study site
Stockholm
Study site
Sundsvall
Study site
Uddevalla
Study site
Uppsala
Czechia4 sites
Study site
Ostrava
Study site
Pilsen
Study site
Prague
Study site
Ústí nad Labem
Denmark4 sites
Study site
Aalborg
Study site
Frederiksberg
Study site
Roskilde
Study site
Skejby
United Kingdom4 sites
Study site
Cardiff, Wales
Study site
Chorley, Lancashire
Study site
Reading, Berkshire
Study site
Swansea, Wales
Austria3 sites
Study site
Graz, Styria
Study site
Linz, North-West
Study site
Vienna, State of Vienna
About this 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)
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.
Read the 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
- Being tested
- tamsulosin hydrochloride, solifenacin succinate, Placebo
- Keywords
- Lower Urinary Tract Symptoms, Treatment, Solifenacin succinate, Tamsulosin hydrochloride, Prostatic Hyperplasia
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamsulosin hydrochlorideDrug
Alphablocker
solifenacin succinateDrug
antimuscarinic
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: Placebo |
| B | Active comparator | Not described Receives: Drug: solifenacin succinate |
| C | Active comparator | Not described Receives: Drug: solifenacin succinate |
| D | Active comparator | Not described Receives: Drug: solifenacin succinate |
| E | Active comparator | Not described Receives: Drug: tamsulosin hydrochloride |
| F | Active comparator | Not described Receives: Drug: tamsulosin hydrochloride; Drug: solifenacin succinate |
| G | Active comparator | Not described Receives: Drug: tamsulosin hydrochloride; Drug: solifenacin succinate |
| H | Active comparator | Not described Receives: Drug: tamsulosin hydrochloride; Drug: solifenacin succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (1)
Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startJan 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 919 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510406
- Sponsor's protocol ID
- 905-CL-052
- Other IDs
- EudraCT number: 2006-002072-18
- Acronym
- SATURN
- Status last verified
- Aug 2014
- First submitted
- 31 Jul 2007
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23537687
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00510406
- Acronym / sponsor ID
- SATURN / 905-CL-052
- Keywords
- Lower Urinary Tract Symptoms, Treatment, Solifenacin succinate, Tamsulosin hydrochloride, Prostatic Hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 919 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 2 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Placebo |
| B | Active comparator | Drug: solifenacin succinate |
| C | Active comparator | Drug: solifenacin succinate |
| D | Active comparator | Drug: solifenacin succinate |
| E | Active comparator | Drug: tamsulosin hydrochloride |
| F | Active comparator | Drug: tamsulosin hydrochloride, Drug: solifenacin succinate |
| G | Active comparator | Drug: tamsulosin hydrochloride, Drug: solifenacin succinate |
| H | Active comparator | Drug: tamsulosin hydrochloride, Drug: solifenacin succinate |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- post void residual volume > 200 mL
- symptomatic urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tamsulosin hydrochlorideAlphablocker | Drug | E, F, G, H |
| solifenacin succinateantimuscarinic | Drug | B, C, D, F, G, H |
| PlaceboPlacebo | Drug | A |
Primary outcome
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
1 secondary outcome
Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
- Derived from this study: PubMed 23537687Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Central Contact study director
Astellas Pharma Europe B.V.
98 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tamsulosin hydrochloride and solifenacin succinate in people with Lower Urinary Tract Symptoms and Prostatic Hyperplasia, run by Astellas Pharma Inc at 98 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in Germany, France, Netherlands, Poland, Hungary and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00510406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.