Benign Prostate HyperplasiaPhase 2NCT02038868
A Study to Evaluate the Efficacy and Safety of ASP4901 in Patients With Benign Prostate Hyperplasia
A Phase 2 study testing ASP4901 and Tamsulosin in people with Benign Prostate Hyperplasia, run by Astellas Pharma Inc at 2 sites in Japan.
Trial summary
The purpose of this study is to compare the efficacy of ASP4901 with placebo in patients with benign prostatic hyperplasia. The safety and tolerability of ASP4901 will also be evaluated. Read more about this study
- Who is it for?
- Ages 40 to 74 years, men only
- Conditions the study is for
- Benign Prostate Hyperplasia
- What is being tested?
- ASP4901 and Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 2 sitesJapan
- Study dates
- 22 Jul 2013to 4 Apr 2014
- 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 40 to 74 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dysuria associated with BPH for at least 12 weeks before providing consent
- a total IPSS core of 13 or higher
- a QOL score of 3 or higher
- a maximum urinary flow rate (Qmax) of ≥4 mL/sec and <15 mL/sec.
- a prostate volume of ≥20 mL.
Who cannot join
- A postvoid residual volume (PVR) of >350 mL
- A previous or concurrent symptomatic urinary tract infection within 4 weeks of the study
- A cataract operation scheduled to be performed during the study period
- Previous or concurrent clinically relevant cardiovascular or cerebrovascular disorder within 24 weeks prior to the study
- Hypersensitivity to ASP4901 or tamsulosin hydrochloride
- Presence of serious hepatic diseases, renal diseases, immunological diseases, or pulmonary diseases that are clinically relevant
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Double-Blind, Placebo-Controlled, Active-Referenced, Parallel-Group Comparative Study in Patients With Benign Prostatic Hyperplasia
The purpose of this study is to compare the efficacy of ASP4901 with placebo in patients with benign prostatic hyperplasia. The safety and tolerability of ASP4901 will also be evaluated.
Read the detailed description
This is a multicenter, randomized, parallel-group, placebo-controlled, active-referenced, double-blind study. After obtaining the written consent, patients meeting the eligibility criteria at the preliminary enrollment will receive oral administration of placebo in a single-blinded manner (single-blind placebo run-in period). Then, patients meeting the eligibility criteria at the main enrollment will receive drug or placebo (double-blind treatment period) for 4 weeks. Furthermore, patients will be followed up for 1 week to confirm the safety of the study drugs after the treatment period (safety follow-up period).
- Conditions
- Benign Prostate Hyperplasia
- Being tested
- ASP4901, Tamsulosin, Placebo
- Keywords
- ASP4901, BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP4901Drug
oral
TamsulosinDrug
Also called YM617, Harnal
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP4901 group | Experimental | After the main enrollment, patients will receive an oral dose of ASP4901 once daily for 4 weeks (double-blind treatment period). Receives: Drug: ASP4901 |
| Placebo group | Placebo comparator | After the main enrollment, patients will receive an oral dose of placebo once daily for 4 weeks (double-blind treatment period). Receives: Drug: Placebo |
| Tamsulosin group | Active comparator | After the main enrollment, patients will receive an oral dose of tamsulosin once daily for 4 weeks (double-blind treatment period). Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total IPSS (International Prostate Symptom Score)
Measured: baseline and at the final evaluation (up to 5 weeks)
Secondary outcomes (5)
Change from baseline in each symptom score of IPSS
Measured: baseline and at the final evaluation (up to 5 weeks)
Change from baseline in IPSS QOL (quality of life) score
Measured: baseline and at the final evaluation (up to 5 weeks)
Proportion of IPSS responder
"IPSS responder" is defined as 25% improvement in IPSS
Measured: baseline and at the final evaluation (up to 5 weeks)
Plasma concentration of ASP4901
only for ASP4901 group
Measured: up to 5 weeks
Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study start22 Jul 2013
- Primary completion4 Apr 2014
- Study completion4 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate HyperplasiaStudies 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
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038868
- Sponsor's protocol ID
- 4901-CL-0201
- Status last verified
- Oct 2024
- First submitted
- 15 Jan 2014
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Active-Referenced, Parallel-Group Comparative Study in Patients With Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT02038868
- Acronym / sponsor ID
- 4901-CL-0201
- Conditions
- Benign Prostate Hyperplasia
- Keywords
- ASP4901, BPH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2013 (actual)
- Primary completion
- 4 Apr 2014 (actual)
- Study completion
- 4 Apr 2014 (actual)
- First posted
- 17 Jan 2014 (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 purpose of this study is to compare the efficacy of ASP4901 with placebo in patients with benign prostatic hyperplasia. The safety and tolerability of ASP4901 will also be evaluated.
Detailed description
This is a multicenter, randomized, parallel-group, placebo-controlled, active-referenced, double-blind study. After obtaining the written consent, patients meeting the eligibility criteria at the preliminary enrollment will receive oral administration of placebo in a single-blinded manner (single-blind placebo run-in period). Then, patients meeting the eligibility criteria at the main enrollment will receive drug or placebo (double-blind treatment period) for 4 weeks. Furthermore, patients will be followed up for 1 week to confirm the safety of the study drugs after the treatment period (safety follow-up period).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASP4901 group | Experimental | Drug: ASP4901After the main enrollment, patients will receive an oral dose of ASP4901 once daily for 4 weeks (double-blind treatment period). |
| Placebo group | Placebo comparator | Drug: PlaceboAfter the main enrollment, patients will receive an oral dose of placebo once daily for 4 weeks (double-blind treatment period). |
| Tamsulosin group | Active comparator | Drug: TamsulosinAfter the main enrollment, patients will receive an oral dose of tamsulosin once daily for 4 weeks (double-blind treatment period). |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- dysuria associated with BPH for at least 12 weeks before providing consent
- a total IPSS core of 13 or higher
- a QOL score of 3 or higher
- a maximum urinary flow rate (Qmax) of ≥4 mL/sec and <15 mL/sec.
- a prostate volume of ≥20 mL.
Key exclusion criteria (6 listed)
- A postvoid residual volume (PVR) of >350 mL
- A previous or concurrent symptomatic urinary tract infection within 4 weeks of the study
- A cataract operation scheduled to be performed during the study period
- Previous or concurrent clinically relevant cardiovascular or cerebrovascular disorder within 24 weeks prior to the study
- Hypersensitivity to ASP4901 or tamsulosin hydrochloride
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 |
|---|---|---|
| ASP4901oral | Drug | ASP4901 group |
| TamsulosinAlso: YM617, Harnaloral | Drug | Tamsulosin group |
| Placebooral | Drug | Placebo group |
Primary outcome
Change from baseline in total IPSS (International Prostate Symptom Score)
Time frame: baseline and at the final evaluation (up to 5 weeks)
5 secondary outcomes
Change from baseline in each symptom score of IPSS
Time frame: baseline and at the final evaluation (up to 5 weeks)
Change from baseline in IPSS QOL (quality of life) score
Time frame: baseline and at the final evaluation (up to 5 weeks)
Proportion of IPSS responder
Time frame: baseline and at the final evaluation (up to 5 weeks)
Plasma concentration of ASP4901
Time frame: up to 5 weeks
Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs
Time frame: up to 5 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 6 Nov 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Related trials for Benign Prostate Hyperplasia
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
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.
Medical Director study director
Astellas Pharma Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP4901 and Tamsulosin in people with Benign Prostate Hyperplasia, run by Astellas Pharma Inc at 2 sites in Japan.
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 5 inclusion and 6 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 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Change from baseline in total IPSS (International Prostate Symptom Score) (time frame: baseline and at the final evaluation (up to 5 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2024.