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

NCT03246880 | Completed Phase 3

• 1 other identifier: 150BPH15018
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

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

  From baseline at week 12

Secondary Outcomes (2)

• 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

Study Arms (3)

Tamsulosin 0.2mg+Tadalafil 5mg

EXPERIMENTAL

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

Drug: Tamsulosin 0.2mg; Drug: Tadalafil 5mg

Tamsulosin 0.2mg

ACTIVE COMPARATOR

Tamsulosin 0.2mg, po, q.d.

Drug: Tamsulosin 0.2mg

Tadalafil 5mg

ACTIVE COMPARATOR

Tadalafil 5mg, po, q.d.

Drug: Tadalafil 5mg

Interventions

Tamsulosin 0.2mg DRUG

per oral for 12weeks after 2\~4weeks run-in period

Tamsulosin 0.2mg; Tamsulosin 0.2mg+Tadalafil 5mg

Tadalafil 5mg DRUG

per oral for 12weeks after 2\~4weeks run-in period

Tadalafil 5mg; Tamsulosin 0.2mg+Tadalafil 5mg

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Visit 1\]
• 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
• mL/s ≥ Qmax ≥ 4mL/s, if voided volume ≥ 120ml
• PVR(post-void residual urine volume) ≤ 250ml

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin; Tadalafil

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Myung-Soo Choo, M.D., Ph.D

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: August 11, 2017
• Study Start: September 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

KR (1)