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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020369
Receipt No. R000023411
Scientific Title A Randomized, Open-Label, Multicenter study evaluating efficacy of switch from dutasteride to tadalafil in benign prostatic hyperplasia patient with lower urinary tract symptoms
Date of disclosure of the study information 2016/01/20
Last modified on 2018/12/29

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Basic information
Public title A Randomized, Open-Label, Multicenter study evaluating efficacy of switch from dutasteride to tadalafil in benign prostatic hyperplasia patient with lower urinary tract symptoms
Acronym Switch from dutasteride to tadalafil in patent with benign prostatic hyperplasia
Scientific Title A Randomized, Open-Label, Multicenter study evaluating efficacy of switch from dutasteride to tadalafil in benign prostatic hyperplasia patient with lower urinary tract symptoms
Scientific Title:Acronym Switch from dutasteride to tadalafil in patent with benign prostatic hyperplasia
Region
Japan

Condition
Condition benign prostatic hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This is a randomized, open-label, multinational, 12-week study to evaluating switching effect from dutasteride to tadalafil in benign prostatic hyperplasia patients with lower urinary tract symptoms.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change from Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS)
Key secondary outcomes Change from Baseline to 12 Week Endpoint in IPSS Irritative Subscore, IPSS Voiding (Obstructive) Subscore, IPSS Quality of Life (QoL) Index, Uroflowmetry Parameter: Peak Flow Rate (Qmax), Number of Participants With Adverse Events International Index of Erectile Function (IIEF), Blood Pressure,ostvoid Residual Volume (PVR), Prostate Specific Antigen (PSA),testosterone, oxygen stress

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tadalafil 5mg one a day, for 12 weeks
Interventions/Control_2 No treatment, observation for 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
99 years-old >=
Gender Male
Key inclusion criteria Males, 20 years or older, with benign prostatic hyperplasia, including lower urinary tract symptoms who were taking dutasteride
Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the study
Have not taken phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 1.
Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of Visit 1.
Key exclusion criteria Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1.
History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.
History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.
Clinical evidence of prostate cancer at Visit 1.
Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.
History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.
Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.
History of drug, alcohol, or substance abuse within the 6 months before Visit 1.
Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to tadalafil.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chikara Ohyama
Organization Hirosaki University Graduate School of Medicine
Division name Department of Urology
Zip code
Address 5 Zaifu-chou, Hirosaki, Japan
TEL +81172395091
Email shingorilla2@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University Graduate School of Medicine
Division name Department of Urology
Zip code
Address 5 Zaifu-chou, Hirosaki, Japan
TEL +81172395091
Homepage URL
Email shingorilla2@gmail.com

Sponsor
Institute Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 20 Day
Last follow-up date
2018 Year 12 Month 29 Day
Date of closure to data entry
2018 Year 12 Month 29 Day
Date trial data considered complete
2018 Year 12 Month 29 Day
Date analysis concluded
2018 Year 12 Month 29 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 27 Day
Last modified on
2018 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023411

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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