Study of Tadalafil Once-a-Day for 12 Weeks in Japanese Men With Benign Prostatic Hyperplasia Followed by an Open-Label Extension

Eli Lilly and Company422 enrolled

Overview

This study is a randomized, double-blind, placebo-controlled, parallel-design to compare the efficacy and safety of tadalafil once-a-day dosing versus placebo for 12 weeks followed by an open-label extension to evaluate the long-term safety and efficacy of tadalafil in Japanese men with signs and symptoms of benign prostatic hyperplasia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

422

Conditions

Benign Prostatic Hyperplasia

Interventions

Tadalafil 2.5 mgDRUG

oral, daily

Tadalafil 5 mgDRUG

oral, daily

PlaceboDRUG

oral, daily

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Japanese Males, 45 years old or older, with benign prostatic hyperplasia (BPH) for at least 6 months prior to Visit 1 and an International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2. * Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments at any time during the study. * Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to Visit 2. Exclusion Criteria: * Prostate specific antigen (PSA) score beyond acceptable range defined for study at Visit 1. * History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1. * History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1. * Clinical evidence of prostate cancer at Visit 1. * Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1. * History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study. * History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. * Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.

Locations (6)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Chiba, Japan

Outcomes

Primary Outcomes

Change From Baseline in International Prostate Symptom Score (IPSS) Total Score at 12-Week Endpoint

The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.

Time frame: Baseline, 12 weeks

Secondary Outcomes

Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12-Week Endpoint

IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15.

Time frame: Baseline, 12 weeks

Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12-Week Endpoint

IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (not at all) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20.

Time frame: Baseline, 12 weeks

Change From Baseline in IPSS Quality of Life (QoL) Index at 12-Week Endpoint

Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).

Time frame: Baseline, 12 weeks

Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 12-Week Endpoint

The OABSS is a four-symptom questionnaire to assess overactive bladder (OAB) symptoms: daytime frequency, nighttime frequency, urgency, and urgency incontinence. Scores range from 0 - 15, with higher scores indicating more severe OAB symptoms.

Time frame: Baseline, 12 weeks

Data from ClinicalTrials.gov

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Kanagawa, Japan

Kyoto, Japan

Osaka, Japan

Tokyo, Japan

Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12-Week Endpoint

Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).

Time frame: Baseline, 12 weeks

Tadalafil Pharmacokinetics in Japanese Men: Plasma Concentration Measurement

Plasma from participants in the tadalafil treatment groups were assayed using a validated liquid chromatographic/mass spectrometric (LC/MS) method.

Time frame: Baseline, 12 weeks

Number of Participants With Adverse Events During 12 Weeks of the Study

A listing of Adverse Events are reported in the Reported Adverse Event Section.

Time frame: Baseline through 12 weeks

Change From Baseline in Blood Pressure at 12-Week Endpoint

Time frame: Baseline, 12 weeks

Change From Baseline in Sitting Heart Rate at 12-Week Endpoint

Time frame: Baseline, 12 Weeks

Change From Baseline in Postvoid Residual Volume (PVR) at 12-Week Endpoint

Postvoid residual volume (PVR) is measured by ultrasound at regular intervals.

Time frame: Baseline, 12 weeks

Change From Baseline in Prostate Specific Antigen (PSA) at 12-Week Endpoint

Measurement of nanograms of PSA per milliliter (ng/mL) of blood.

Time frame: Baseline, 12 weeks

Change From Baseline in the International Prostate Symptom Score (IPSS) Total Score at 54-Week Endpoint

Time frame: Baseline, 54 weeks

Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 54-Week Endpoint

Time frame: Baseline, 54 weeks

Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 54-Week Endpoint

Time frame: Baseline, 54 weeks

Change From Baseline in IPSS Quality of Life (QoL) Index at 54-Week Endpoint

Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).

Time frame: Baseline, 54 weeks

Change From Baseline in Overactive Bladder Symptom Score (OABSS) at 54-Week Endpoint

Time frame: Baseline, 54 weeks

Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 54-Week Endpoint

Uroflowmetry was assessed by Qmax, defined as the peak urine flow rate (measured in mL/second using a standard calibrated flowmeter).

Time frame: Baseline, 54 weeks

Number of Participants With Adverse Events During 42 Weeks of Open-Label Treatment

A listing of Adverse Events are reported in the Reported Adverse Event Section.

Time frame: End of 12 weeks of double-blind through 54 weeks

Change From Baseline in Blood Pressure During at 54-Week Endpoint

Time frame: Baseline, 54 weeks

Change From Baseline in Sitting Heart Rate at 54-Week Endpoint

Time frame: Baseline, 54-weeks

Change From Baseline in Prostate Specific Antigen (PSA) at 54-Week Endpoint

Measurement of nanograms of PSA per milliliter (ng/mL) of blood.

Time frame: Baseline, 54 weeks

Change From Baseline in Postvoid Residual Volume (PVR) at 54-Week Endpoint

Post residual volume (PVR) is measured by ultrasound at regular intervals.

Time frame: Baseline, 54 weeks