Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Eli Lilly and Company612 enrolled

Overview

This study is a randomized, double-blind, placebo and tamsulosin-controlled, parallel design, multinational study to evaluate the efficacy and safety of Tadalafil once-a-day dosing for 12 weeks in Asian men with signs and symptoms of benign prostatic hyperplasia (BPH).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

612

Conditions

Benign Prostatic Hyperplasia

Interventions

TadalafilDRUG

by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks

PlaceboDRUG

PO, QD (30 min after meal) for 12 weeks

TamsulosinDRUG

PO, QD (30 min after meal) for 12 weeks

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Asian males, with benign prostatic hyperplasia (BPH) for at least 6 months prior to initiation and IPSS score greater than or equal to 13 at the beginning of the treatment * Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and 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 the beginning of the treatment Exclusion Criteria: * Prostate specific antigen (PSA) score beyond acceptable range defined for study at initiation * History of urinary retention or lower urinary tract (bladder) stones within 6 months of initiation * History of urinary urethral obstruction due to stricture, valves, sclerosis, or tumor at initiation * Clinical evidence of prostate cancer at initiation * Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at initiation * 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 injuries (including stroke or spinal cord injury within 6 months of initiation) * Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH)agonists/antagonists, or anabolic steroids at initiation

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.

Hyōgo, Japan

Outcomes

Primary Outcomes

Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks

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. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.

Time frame: baseline, 12 weeks

Secondary Outcomes

Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive])

IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms); 4 questions of the obstructive score range from 0 to 20. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); 3 questions of the irritative subscore range from 0 to 15. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.

Time frame: baseline, 12 weeks

Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks

Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). Least Squares Mean values were controlled for Benign Prostatic Hyperplasia severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.

Time frame: baseline, 12 weeks

Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks

The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least Squares Mean values were controlled for BPH severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.

Data from ClinicalTrials.gov

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