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

NCT00861757 | Completed Phase 3 Results

• 2 other identifiers: 10487H6D-MC-LVHB
• Study Type: interventional
• Target: 612
• Locations: 2 countries
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 12 weeks

Secondary Outcomes (11)

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

  baseline, 12 weeks

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

  baseline, 12 weeks

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

  baseline, 12 weeks

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

  baseline, 12 weeks

• Patient Global Impression of Improvement (PGI-I) at Week 12

  12 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

2.5 mg Tadalafil

EXPERIMENTAL

Drug: Tadalafil

5.0 mg Tadalafil

EXPERIMENTAL

Drug: Tadalafil

0.2 mg Tamsulosin

ACTIVE COMPARATOR

Drug: Tamsulosin

Interventions

Tadalafil DRUG

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

Also known as: LY450190, Cialis

2.5 mg Tadalafil; 5.0 mg Tadalafil

Placebo DRUG

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

Placebo

Tamsulosin DRUG

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

0.2 mg Tamsulosin

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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.

Hyōgo, 663-8006, 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, 565-0854, 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, 130-0026, 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.

Kaohsiung City, 813, Taiwan

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.

Taipei, 100, Taiwan

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.

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tadalafil; Tamsulosin

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; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

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 3
• 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: March 12, 2009
• First Posted: March 13, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 28, 2011
• Results First Posted: June 13, 2011

Record last verified: 2011-06

Locations

TW (3); JP (3)