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

NCT ID: NCT00861757

Last Updated: 2011-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 612 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-06-30

Brief Summary

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).

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

2.5 mg Tadalafil

Group Type: EXPERIMENTAL

Tadalafil

Intervention Type: DRUG

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

5.0 mg Tadalafil

Group Type: EXPERIMENTAL

Tadalafil

Intervention Type: DRUG

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

0.2 mg Tamsulosin

Group Type: ACTIVE_COMPARATOR

Tamsulosin

Intervention Type: DRUG

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

Interventions

Tadalafil

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Tamsulosin

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

Intervention Type: DRUG

Other Intervention Names

LY450190, Cialis

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Eli Lilly

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

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, , Japan

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, , Japan

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 City, , Taiwan

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, , Taiwan

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.

Taoyuan District, , Taiwan

Countries

Japan; Taiwan

Other Identifiers

H6D-MC-LVHB

Identifier Type: OTHER

Identifier Source: secondary_id

10487

Identifier Type: -

Identifier Source: org_study_id