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

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 Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Tamsulosin 0.2mg; Drug: Tadalafil 5mg

• Study Type: Interventional
• Enrollment (Actual): 455
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tamsulosin 0.2mg+Tadalafil 5mg; Tamsulosin 0.2mg+Tadalafil 5mg, po, q.d.	Drug: Tamsulosin 0.2mg; per oral for 12weeks after 2~4weeks run-in period; Drug: Tadalafil 5mg; per oral for 12weeks after 2~4weeks run-in period
Active Comparator: Tamsulosin 0.2mg; Tamsulosin 0.2mg, po, q.d.	Drug: Tamsulosin 0.2mg; per oral for 12weeks after 2~4weeks run-in period
Active Comparator: Tadalafil 5mg; Tadalafil 5mg, po, q.d.	Drug: Tadalafil 5mg; per oral for 12weeks after 2~4weeks run-in period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score )	From baseline at week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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		From baseline at week 8

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Myung-Soo Choo, M.D., Ph.D, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 2, 2015
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tadalafil; Tamsulosin
• Other Study ID Numbers: 150BPH15018