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A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00848081
First received: February 19, 2009
Last updated: August 16, 2010
Last verified: August 2010
History of Changes
Results First Received: August 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Benign Prostatic Hyperplasia
Interventions: Drug: Tadalafil
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Placebo by mouth once daily for 12 weeks
Tadalafil Tadalafil 5 mg taken by mouth once daily for 12 weeks

Participant Flow:   Overall Study
    Placebo     Tadalafil  
STARTED     160     158  
COMPLETED     140     140  
NOT COMPLETED     20     18  
Adverse Event                 6                 7  
Protocol Violation                 8                 5  
Lost to Follow-up                 1                 0  
Physician Decision                 0                 3  
Withdrawal by Subject                 5                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Placebo by mouth once daily for 12 weeks
Tadalafil Tadalafil 5 mg taken by mouth once daily for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     Tadalafil     Total  
Number of Participants  
[units: participants]
 		  160     158     318  
Age  
[units: years]
Mean ± Standard Deviation 		  67.35  ± 9.13     67.41  ± 9.11     67.38  ± 9.10  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     160     158     318  
Ethnicity (NIH/OMB)  
[units: Participants]
 		     
Hispanic or Latino     18     20     38  
Not Hispanic or Latino     142     138     280  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB) [1]
[units: Participants]
 		     
American Indian or Alaska Native     1     0     1  
Asian     1     1     2  
Native Hawaiian or Other Pacific Islander     0     1     1  
Black or African American     14     17     31  
White     144     137     281  
More than one race     0     2     2  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     157     148     305  
Puerto Rico     3     10     13  
[1] If a subject reported multiple race categories, he was counted as “more than one race” but not in any single category.



  Outcome Measures
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1.  Primary:   Number of Men With Treatment-emergent Dizziness   [ Time Frame: Baseline through 12 Weeks ]
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2.  Secondary:   Number of Participants With Positive Orthostatic Vital Signs Test; Shift From Any Pre-Randomization to Any Post-Randomization Visit   [ Time Frame: Baseline through 12 Weeks ]
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3.  Secondary:   International Prostate Symptom Score (IPSS) Change From Baseline   [ Time Frame: Baseline, 12 Weeks ]
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4.  Secondary:   Postvoid Residual Volume (PVR) Change From Baseline   [ Time Frame: Baseline, 12 Weeks ]
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5.  Secondary:   Uroflowmetry (Qmax) Change From Baseline   [ Time Frame: Baseline, 12 Weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Chief medical officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00848081     History of Changes
Other Study ID Numbers: 11668, H6D-MC-LVHS
Study First Received: February 19, 2009
Results First Received: August 16, 2010
Last Updated: August 16, 2010
Health Authority: United States: Food and Drug Administration