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Sponsored by: |
Eli Lilly and Company |
---|---|
Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00861757 |
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 |
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 |
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
|
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) | 1-317-615-4559 |
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 |
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 |
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 |
Signs and Symptoms Neurotransmitter Agents Hyperplasia Phosphodiesterase Inhibitors Adrenergic Agents Prostatic Diseases |
Prostatic Hyperplasia Tadalafil Tamsulosin Adrenergic Antagonists Adrenergic alpha-Antagonists Genital Diseases, Male |
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 |