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

NCT00783094 | Completed Phase 2 Results

• 2 other identifiers: 12757H6D-JE-LVIA
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 12 weeks

Secondary Outcomes (22)

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

  Baseline, 12 weeks

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

  Baseline, 12 weeks

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

  Baseline, 12 weeks

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

  Baseline, 12 weeks

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

  Baseline, 12 weeks

Study Arms (3)

Tadalafil 2.5 milligrams (mg)

EXPERIMENTAL

2.5 mg tadalafil tablet by mouth once a day for 12 weeks followed by 5 mg tadalafil tablet by mouth once a day for 42 weeks.

Drug: Tadalafil 2.5 mg

Tadalafil 5 mg

EXPERIMENTAL

5 mg tadalafil tablet by mouth once a day for 12 weeks then continue 5 mg tadalafil tablet by mouth once a day for 42 weeks.

Drug: Tadalafil 5 mg

Placebo

PLACEBO COMPARATOR

Placebo tablet taken by mouth once a day for 12 weeks. Then subjects may take 5 mg tadalafil tablet by mouth once a day for 42 weeks.

Drug: Placebo

Interventions

Tadalafil 2.5 mg DRUG

oral, daily

Also known as: LY450190, Cialis

Tadalafil 2.5 milligrams (mg)

Tadalafil 5 mg DRUG

oral, daily

Also known as: LY450190, Cialis

Tadalafil 5 mg

Placebo DRUG

oral, daily

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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, 274-0825, Japan

Location

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.

Hiroshima, 730-0013, Japan

Location

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.

Kanagawa, 226-0025, Japan

Location

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.

Kyoto, 607-8085, Japan

Location

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, 561-0832, Japan

Location

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, 150-0002, Japan

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: October 31, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: April 1, 2010
• Last Updated: March 29, 2011
• Results First Posted: July 28, 2010

Record last verified: 2011-03

Locations

JP (6)