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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016796
Receipt No. R000019497
Scientific Title Efficacy and Safety of the Coadministration of Tadarafil with Dutasteride in Men with Benign Prostatic Hyperplasia: A Phase III Randomized Open-Label Study
Date of disclosure of the study information 2015/03/15
Last modified on 2017/09/13

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Basic information
Public title Efficacy and Safety of the Coadministration of Tadarafil with Dutasteride in Men with Benign Prostatic Hyperplasia: A Phase III Randomized Open-Label Study
Acronym CoaTAD study
Scientific Title Efficacy and Safety of the Coadministration of Tadarafil with Dutasteride in Men with Benign Prostatic Hyperplasia: A Phase III Randomized Open-Label Study
Scientific Title:Acronym CoaTAD study
Region
Japan

Condition
Condition Benign Prostatic Hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyse the efficacy and safety of the coadministration of Tadarafil and Dutasteride for Benign Prostatic Hyperplasis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Total international prostate symptom score on 12 weeks after administration
Key secondary outcomes Total IPSS on 24 weeks after administration
IPSS sub-score, OABSS, IIEF, EHS, AMS Score, Uroflowmetry, Post-voided residual volume, adverse effect, BMI, blood pressure, waist size, prostate volume, Plaque score on 4, 12, and 24 weeks

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dutasteride+Tadarafil
Interventions/Control_2 Dutasteride alone
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Male aged 50 or higher with prostate volume of 30 ml or higher and IPSS of 8 or higher
Key exclusion criteria 1) Prostate cancer
2) Nerogenic bladder
3) no administration of Dutasteride, Finasteride, anti-androgen, and testosterone within 6 months
4) no administration of drugs for overactive bladder and BPH exclude a1-blocker
5) no administration of PDE5 inhibitors
6) contraindication of Dutasteride
7) contraindication of Tadarafil
Target sample size 560

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhide Kitagawa
Organization Kanazawa University Graduate School of Medical Science
Division name Integrative Cancer Therapy and Urology
Zip code
Address Takaramachi 13-1, Kanazawa, Japan
TEL 076-265-2393
Email yasukita@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhide Kitagawa
Organization Kanazawa University Graduate School of Medical Science
Division name Integrative Cancer Therapy and Urology
Zip code
Address Takaramachi 13-1, Kanazawa, Japan
TEL 076-265-2393
Homepage URL
Email yasukita@med.kanazawa-u.ac.jp

Sponsor
Institute Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science
Institute
Department

Funding Source
Organization Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2015 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2015 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 13 Day
Last modified on
2017 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019497

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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