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

Condition(s) targeted: Benign Prostatic Hyperplasia

Intervention: Tadalafil (Drug); Placebo (Drug); Tamsulosin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

Overall contact:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559), Phone: 1-317-615-4559

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)

Official title: A Phase 3, 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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: International Prostate Symptom Score (IPSS)

Secondary outcome:

IPSS subscore (storage and voiding)

IPSS Quality of Life (QoL)

Benign Prostate Hyperplasia Impact Index (BII)

Uroflowmetry parameter: Peak flow rate (Qmax)

Patient Global Impression of Improvement (PGI-I)

Clinician Global Impression of Improvement (CGI-I)

Prostate Specific Antigen (PSA)

Postvoid Residual Volume (PVR)

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Asian males, with benign prostatic hyperplasia 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,ED and 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:

- 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

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559), Phone: 1-317-615-4559

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., Saga 847-0011, Japan; Recruiting
Eli Lilly

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., Hyogo 663-8006, Japan; Recruiting
Eli Lilly

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., Fukuoka 816-0952, Japan; Recruiting
Eli Lilly

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., Saitama 330-0074, Japan; Recruiting
Eli Lilly

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., Tokyo 130-0026, Japan; Recruiting
Eli Lilly

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., Osaka 565-0854, Japan; Recruiting
Eli Lilly

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., Jeon Ju-City 561-712, Korea, Republic of; Active, not recruiting

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., Kangnam-Gu 135-710, Korea, Republic of; Active, not recruiting

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., Kwang Ju 501-757, Korea, Republic of; Active, not recruiting

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., Pusan 609 735, Korea, Republic of; Active, not recruiting

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., Seoul 137-040, Korea, Republic of; Active, not recruiting

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., Kaohsiung 813, Taiwan; Recruiting
Eli Lilly

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., Taipei 100, Taiwan; Recruiting
Eli Lilly

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., Tao-Yuan 333, Taiwan; Recruiting
Eli Lilly

Starting date: March 2009
Ending date: February 2010
Last updated: October 5, 2009