Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients

Chong Kun Dang

Status and phase: Completed; Phase 3

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Tamsulosin 0.2mg; Drug: Tadalafil 5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03246880

150BPH15018

Details and patient eligibility

About

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.

Enrollment: 455 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

[Visit 1]

1. Male Aged of 45 or above
2. Patients must have a diagnosis of Benign Prostatic Hyperplasia
3. IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13
4. Signed and dated informed consent document indicating that the patient

[Visit 2]

1. IPSS(International Prostate Symptom Score) questionnaire total score ≥ 13
2. 15mL/s ≥ Qmax ≥ 4mL/s, if voided volume ≥ 120ml
3. PVR(post-void residual urine volume) ≤ 250ml

Exclusion criteria

1. Patients have ever taken Finasteride in 3 months or Dutasteride in 6 months
2. Patients with prostate cancer or PSA > 10ng/ml
3. Patients with other disease which could have influence on urine flow rate except BPH(benign prostatic hyperplasia )
4. Patients with a history of operation on prostate which could have influence on the result and need to have surgery.
5. Patients with acute urinary retention in 3months
6. Patients with a history of drug or alcohol abuse within 6 months
7. Patients have cardiovascular disease or associated disease which is not controlled.
8. Patients who need to take Nitrates, alpha blocker, Nitric Oxide Donor
9. Patients with orthostatic hypotension
10. Patients with a history micturition syncope
11. Patients with severe or malignant retinopathy
12. Patients have a visual disturbance by Non-arteritic anterior ischemic optic neuropathy
13. Patients with a congestive disease like galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
14. Serum creatinine > upper Normal Limit*2, AST/ALT > upper Normal Limit*3
15. Patient with uncontrolled diabetes(HbA1C>9%)
16. Patients have a history of malignant tumor within 5 years
17. Patients have hypersensitivity reaction on this drug.
18. Patients treated with other investigational product within 4 weeks at first time taking the investigational product
19. Not eligible to participate for the study at the discretion of investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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455 participants in 3 patient groups

Tamsulosin 0.2mg+Tadalafil 5mg

Experimental group

Description:

Tamsulosin 0.2mg+Tadalafil 5mg, po, q.d.

Treatment:

Drug: Tadalafil 5mg

Drug: Tamsulosin 0.2mg

Tamsulosin 0.2mg

Active Comparator group

Description:

Tamsulosin 0.2mg, po, q.d.

Treatment:

Drug: Tamsulosin 0.2mg

Tadalafil 5mg

Active Comparator group

Description:

Tadalafil 5mg, po, q.d.

Treatment:

Drug: Tadalafil 5mg