Status:
COMPLETED
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
45+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- \[Visit 1\]
- 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
- \[Visit 2\]
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
455 Patients enrolled
Trial Details
Trial ID
NCT03246880
Start Date
September 1 2015
End Date
May 1 2016
Last Update
August 11 2017
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea