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

Chong Kun Dang Pharmaceutical1 site in 1 country455 target enrollmentSeptember 2015

ConditionsBenign Prostatic Hyperplasia

InterventionsTadalafil 5mg Tamsulosin 0.2mg

DrugsTamsulosin 0.2mg Tadalafil 5mg

Overview

Phase: Phase 3
Intervention: Tadalafil 5mg
Conditions: Benign Prostatic Hyperplasia
Sponsor: Chong Kun Dang Pharmaceutical
Enrollment: 455
Locations: 1
Primary Endpoint: The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score )
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

May 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Chong Kun Dang Pharmaceutical

Responsible Party

Sponsor

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

Arms & Interventions

Tadalafil 5mg

Tadalafil 5mg, po, q.d.

Intervention: Tadalafil 5mg

Tamsulosin 0.2mg+Tadalafil 5mg

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

Intervention: Tamsulosin 0.2mg

Tamsulosin 0.2mg+Tadalafil 5mg

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

Intervention: Tadalafil 5mg

Tamsulosin 0.2mg

Tamsulosin 0.2mg, po, q.d.

Intervention: Tamsulosin 0.2mg

Outcomes

Primary Outcomes

The mean change of the total score on IPSS questionnaire(International Prostate Symptom Score )

Time Frame: From baseline at week 12

Secondary Outcomes

The mean change of scores on three questionnaire, Qmax(maximum flow rate(urine), PVR(post-void residual urine volume)(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)