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Multinational Study to Evaluate Tadalafil in Asian Men With of Benign Prostatic Hyperplasia
This study is currently recruiting participants.
Verified by Eli Lilly and Company, April 2009
First Received: March 12, 2009   Last Updated: April 20, 2009   History of Changes
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00861757
  Purpose

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)


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: Tadalafil
Drug: Placebo
Drug: Tamsulosin
Phase III

Drug Information available for: Tamsulosin Tamsulosin hydrochloride Tadalafil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • International Prostate Symptom Score (IPSS) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IPSS subscore (storage and voiding) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • IPSS Quality of Life (QoL) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Benign Prostate Hyperplasia Impact Index (BII) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Uroflowmetry parameter: Peak flow rate (Qmax) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Improvement (PGI-I) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Clinician Global Impression of Improvement (CGI-I) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Prostate Specific Antigen (PSA) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Postvoid Residual Volume (PVR) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 560
Study Start Date: March 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
5mg Tadalafil: Experimental Drug: Tadalafil
PO, QD (30min after meal) for 12 weeks
Placebo: Placebo Comparator Drug: Placebo
PO, QD (30min after meal) for 12 weeks
0.2mg Tamsulosin: Active Comparator Drug: Tamsulosin
PO, QD (30min after meal) for 12 weeks
2.5mg Tadalafil: Experimental Drug: Tadalafil
PO, QD (30min after meal) for 12 weeks

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861757

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) 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
Saga, Japan, 847-0011
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
Hyogo, Japan, 651-0094
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
Hyougo, Japan, 663-8003
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, 130-0026
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
Saitama, Japan, 330-0074
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, 565-0854
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
Fukuoka, Japan, 816-0952
Contact: Eli Lilly            
Korea, Republic of
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
Jeon Ju-City, Korea, Republic of, 561-712
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
Kangnam-Gu, Korea, Republic of, 135-710
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
Kwang Ju, Korea, Republic of, 501-757
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
Pusan, Korea, Republic of, 609 735
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
Seoul, Korea, Republic of, 140-757
Contact: Eli Lilly            
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. Not yet recruiting
Kaohsiung, Taiwan, 813
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. Not yet recruiting
Tao-Yuan, Taiwan, 333
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
Taipei, Taiwan, 100
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

No publications provided

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 10487, H6D-MC-LVHB
Study First Received: March 12, 2009
Last Updated: April 20, 2009
ClinicalTrials.gov Identifier: NCT00861757     History of Changes
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency;   Korea: Food and Drug Administration;   Taiwan: Department of Health

Study placed in the following topic categories:
Signs and Symptoms
Neurotransmitter Agents
Hyperplasia
Phosphodiesterase Inhibitors
Adrenergic Agents
Prostatic Diseases
Prostatic Hyperplasia
Tadalafil
Tamsulosin
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Genital Diseases, Male

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Adrenergic Agents
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Adrenergic alpha-Antagonists
Genital Diseases, Male
Pharmacologic Actions
Hyperplasia
Phosphodiesterase Inhibitors
Pathologic Processes
Prostatic Hyperplasia
Therapeutic Uses
Tamsulosin
Tadalafil
Adrenergic Antagonists

ClinicalTrials.gov processed this record on May 07, 2009