CompletedInterventionalPhase 2Updated Nov 25, 2010
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients | NCT03246880 | Trialant
CompletedInterventionalPhase 3Updated Aug 11, 2017
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients
ClinicalTrials.gov ID
NCT03246880
Lead Sponsor
Chong Kun Dang PharmaceuticalINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
455Actual
Last Update Posted
Aug 11, 2017Actual
Start Date
Sep 2015Actual
Primary Completion Date
Apr 2016Actual
Completion Date
May 2016Actual
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.
Benign Prostatic Hyperplasia
Tamsulosin 0.2mg
Tadalafil 5mg
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
[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 Criteria:
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