Benign Prostatic HyperplasiaPhase 3NCT03246880
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients
A Phase 3 study testing Tamsulosin 0.2mg and Tadalafil 5mg in people with Benign Prostatic Hyperplasia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase III Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Tamsulosin 0.2mg and Tadalafil 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to May 2016
- Phase
- Phase 3
- 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
- [Visit 1]
- Male Aged of 45 or above
- Patients must have a diagnosis of Benign Prostatic Hyperplasia
- IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13
- Signed and dated informed consent document indicating that the patient
- [Visit 2]
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- IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13
- 15mL/s ≥ Qmax ≥ 4mL/s, if voided volume ≥ 120ml
- PVR(post-void residual urine volume) ≤ 250ml
Who cannot join
- Patients have ever taken Finasteride in 3 months or Dutasteride in 6 months
- Patients with prostate cancer or PSA > 10ng/ml
- Patients with other disease which could have influence on urine flow rate except BPH(benign prostatic hyperplasia )
- Patients with a history of operation on prostate which could have influence on the result and need to have surgery.
- Patients with acute urinary retention in 3months
- Patients with a history of drug or alcohol abuse within 6 months
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- Patients have cardiovascular disease or associated disease which is not controlled.
- Patients who need to take Nitrates, alpha blocker, Nitric Oxide Donor
- Patients with orthostatic hypotension
- Patients with a history micturition syncope
- Patients with severe or malignant retinopathy
- Patients have a visual disturbance by Non-arteritic anterior ischemic optic neuropathy
- Patients with a congestive disease like galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Serum creatinine > upper Normal Limit*2, AST/ALT > upper Normal Limit*3
- Patient with uncontrolled diabetes(HbA1C>9%)
- Patients have a history of malignant tumor within 5 years
- Patients have hypersensitivity reaction on this drug.
- Patients treated with other investigational product within 4 weeks at first time taking the investigational product
- Not eligible to participate for the study at the discretion of investigator
Trial locations and contacts
1 site in 1 country.
About this study
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase III Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Tamsulosin 0.2mg, Tadalafil 5mg
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin 0.2mgDrug
per oral for 12weeks after 2~4weeks run-in period
Tadalafil 5mgDrug
per oral for 12weeks after 2~4weeks run-in period
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin 0.2mg+Tadalafil 5mg | Experimental | Tamsulosin 0.2mg+Tadalafil 5mg, po, q.d. Receives: Drug: Tamsulosin 0.2mg; Drug: Tadalafil 5mg |
| Tamsulosin 0.2mg | Active comparator | Tamsulosin 0.2mg, po, q.d. Receives: Drug: Tamsulosin 0.2mg |
| Tadalafil 5mg | Active comparator | Tadalafil 5mg, po, q.d. Receives: Drug: Tadalafil 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score )
Measured: From baseline at week 12
Secondary outcomes (2)
The mean change of scores on three questionnaire, Qmax(maximum flow rate(urine), PVR(post-void residual urine volume)
IPSS questionnaire(International Prostate Symptom Score ), IIEF-5(International Index of Erectile Function-5) questionnaire Change in score, ICIQ-MLUTS(International Consultation on Incontinence Modular Questionnaire-Male Lower Urinary Tract Symptoms) questionnaire Change in score
Measured: From baseline at week 12
The mean change of scores on IPSS ( International Prostate Symptom Score ), ICIQ-MLUTS( International Consultation on Incontinence Modular Questionnaire-Male Lower Urinary Tract Symptoms) questionnaire Change in score
Measured: From baseline at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study startSep 2015
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung-Soo Choo, M.D., Ph.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246880
- Sponsor's protocol ID
- 150BPH15018
- Status last verified
- Aug 2017
- First submitted
- 2 Sep 2015
- Last updated
- 11 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients
- ClinicalTrials.gov ID
- NCT03246880
- Acronym / sponsor ID
- 150BPH15018
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 Aug 2017 (actual)
- 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.
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase III Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin 0.2mg+Tadalafil 5mg | Experimental | Drug: Tamsulosin 0.2mg, Drug: Tadalafil 5mgTamsulosin 0.2mg+Tadalafil 5mg, po, q.d. |
| Tamsulosin 0.2mg | Active comparator | Drug: Tamsulosin 0.2mgTamsulosin 0.2mg, po, q.d. |
| Tadalafil 5mg | Active comparator | Drug: Tadalafil 5mgTadalafil 5mg, po, q.d. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- [Visit 1]
- Male Aged of 45 or above
- Patients must have a diagnosis of Benign Prostatic Hyperplasia
- IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13
- Signed and dated informed consent document indicating that the patient
Key exclusion criteria (19 listed)
- Patients have ever taken Finasteride in 3 months or Dutasteride in 6 months
- Patients with prostate cancer or PSA > 10ng/ml
- Patients with other disease which could have influence on urine flow rate except BPH(benign prostatic hyperplasia )
- Patients with a history of operation on prostate which could have influence on the result and need to have surgery.
- Patients with acute urinary retention in 3months
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 0.2mgper oral for 12weeks after 2~4weeks run-in period | Drug | Tamsulosin 0.2mg, Tamsulosin 0.2mg+Tadalafil 5mg |
| Tadalafil 5mgper oral for 12weeks after 2~4weeks run-in period | Drug | Tadalafil 5mg, Tamsulosin 0.2mg+Tadalafil 5mg |
Primary outcome
The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score )
Time frame: From baseline at week 12
2 secondary outcomes
The mean change of scores on three questionnaire, Qmax(maximum flow rate(urine), PVR(post-void residual urine volume)
Time frame: From baseline at week 12
The mean change of scores on IPSS ( International Prostate Symptom Score ), ICIQ-MLUTS( International Consultation on Incontinence Modular Questionnaire-Male Lower Urinary Tract Symptoms) questionnaire Change in score
Time frame: From baseline at week 8
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 11 Aug 2017.
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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.
Myung-Soo Choo, M.D., Ph.D principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamsulosin 0.2mg and Tadalafil 5mg in people with Benign Prostatic Hyperplasia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
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 9 inclusion and 19 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 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score ) (time frame: From baseline at week 12). 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 11 Aug 2017.