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

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00783094

Purpose

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.

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Drug: tadalafil Drug: placebo	Phase II

Drug Information available for: Tadalafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Efficacy and Safety of Tadalafil Once-a-Day Dosing 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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

International Prostate Symptom Score (IPSS) total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

International Prostate Symptom Score (IPSS) storage sub score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
International Prostate Symptom Score (IPSS) Voiding sub score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Overactive Bladder Symptom Score (OABSS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Uroflowmetry parameter:peak flow rate (Qmax) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
International Prostate Symptom Score (IPSS) total score [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
International Prostate Symptom Score (IPSS) storage sub score [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
International Prostate Symptom Score (IPSS) Voiding sub score [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
Overactive Bladder Symptom Score (OABSS) [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
Uroflowmetry parameter:peak flow rate (Qmax) [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Vital Signs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Clinical Laboratory Tests [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Prostate Specific Antigen (PSA) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Postvoid Residual Volume (PVR) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Adverse Events [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
Vital Signs [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
Clinical Laboratory Tests [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
Prostate Specific Antigen (PSA) [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
Postvoid Residual Volume (PVR) [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
tadalafil pharmacokinetics in Japanese men [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	420
Study Start Date:	November 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: 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 oral, daily
B: 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 oral, daily
C: 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 oral, daily

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Japanese Males, 45 years old or older, with benign prostatic hyperplasia for at least 6 months prior to Visit 1 and an IPSS score greater than or equal to 13 at Visit 2.
Agree not to use any other approved or experimental pharmacologic BPH, erectile disfunction(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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783094

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Locations

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.	Recruiting
Chiba, Japan, 274-0825
Contact: 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.	Recruiting
Hiroshima, Japan, 730-0013
Contact: 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.	Recruiting
Kyoto, Japan, 607-8085
Contact: 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.	Recruiting
Kanagawa, Japan, 226-0025
Contact: 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.	Recruiting
Osaka, Japan, 561-0832
Contact: 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.	Recruiting
Tokyo, Japan, 150-0002
Contact: Eli Lilly

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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

More Information

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	12757, H6D-JE-LVIA
Study First Received:	October 30, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00783094
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Signs and Symptoms
Hyperplasia
Prostatic Diseases

Prostatic Hyperplasia
Tadalafil
Genital Diseases, Male

Additional relevant MeSH terms:

Phosphodiesterase Inhibitors
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009