A Study of Tadalafil in Men With Benign Prostatic Hyperplasia - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00970632

Purpose

The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Tamsulosin Tamsulosin hydrochloride Tadalafil

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change from baseline to 12 week endpoint in total International Prostate Symptom Score (IPSS) [ Time Frame: baseline (week 0) and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline to 4 weeks and 12 weeks in Benign Prostatic Hyperplasia Impact Index (BII) [ Time Frame: baseline (week 0) and 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
Change from baseline to 12 weeks in International Prostate Symptom Score (IPSS) storage (irritative) subscore [ Time Frame: baseline (week 0) and 12 weeks ] [ Designated as safety issue: No ]
Change from baseline to 12 week endpoint in International Prostate Symptom Score (IPSS) voiding (obstructive) subscore [ Time Frame: baseline (week 0) and 12 weeks ] [ Designated as safety issue: No ]
Change from baseline to 12 week endpoint in International Prostate Symptom Score (IPSS) nocturia subscore [ Time Frame: baseline (week 0) and 12 weeks ] [ Designated as safety issue: No ]
Change from baseline to 12 week endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index [ Time Frame: baseline (week 0) and 12 weeks ] [ Designated as safety issue: No ]
Patient Global Impression of Improvement (PGI-I) at 12 week endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Clinician Global Impression of Improvement (CGI-I) at 12 week endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 week endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline to 1 week in Modified International Prostate Symptom Score (mIPSS) [ Time Frame: baseline (week 0) and 1 week ] [ Designated as safety issue: No ]
Change from baseline to 12 week endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) domain [ Time Frame: baseline (week 0) and 12 weeks ] [ Designated as safety issue: No ]
Change from baseline to 12 week endpoint for peak urine flow rate (Q-Max) and mean urine flow rate (Q-Mean) [ Time Frame: baseline (week 0) and 12 weeks ] [ Designated as safety issue: Yes ]
Change from baseline to 12 week endpoint in Postvoid Residual Volume (PVR) [ Time Frame: baseline (week 0) and 12 weeks ] [ Designated as safety issue: Yes ]
Change from baseline to 4 weeks in total International Prostate Symptom Score (IPSS) [ Time Frame: baseline (week 0) and 4 weeks ] [ Designated as safety issue: No ]
Change from baseline to 12 week endpoint for volume of voided urine (V-Comp) [ Time Frame: baseline (week 0) and 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	453
Study Start Date:	November 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Tadalafil: Experimental Tadalafil tablet and Placebo capsule	Drug: Tadalafil 5mg Tadalafil by mouth daily for 12 weeks Drug: Placebo capsule By mouth daily for 12 weeks
Placebo: Placebo Comparator Placebo tablet and Placebo capsule	Drug: Placebo tablet By mouth daily for 12 weeks Drug: Placebo capsule By mouth daily for 12 weeks
Tamsulosin: Active Comparator Tamsulosin capsule and Placebo tablet	Drug: Placebo tablet By mouth daily for 12 weeks Drug: Tamsulosin 0.4mg Tamsulosin by mouth daily for 12 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Men 45 years of age or older with benign prostatic hyperplasia (BPH) also referred to as BPH-LUTS [lower urinary tract symptoms]) based on the disease diagnostic criteria at the start of study.
Provide signed informed consent at the start of the study.
Agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments anytime during the study.
Have not taken Finasteride therapy for at least 3 months before study drug is dispensed and Dutasteride therapy for at least 6 months before study drug is dispensed.
Have not taken other BPH therapy (including herbal preparations), OAB therapy, ED therapy for at least 4 weeks prior to study drug is dispensed.
Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
Have reduced urine flow (measured by a special toilet equipment).
Demonstrate compliance with study drug administration requirements.

Exclusion Criteria:

Treated with nitrates
Have unstable angina or angina that requires treatment.
Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
Have very high or very low blood pressure.
Have certain neurological conditions associated with bladder problems or injuries to brain or spinal cord within a specified time of starting this study.
Have uncontrolled diabetes.
Have prostate cancer, are being treated for cancer.
Have prostate specific antigen (PSA) greater than 10 ng/ml at the start of study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970632

Contacts

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

1-317-615-4559

Show 45 Study Locations

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:	12932, H6D-MC-LVID
Study First Received:	September 1, 2009
Last Updated:	January 15, 2010
ClinicalTrials.gov Identifier:	NCT00970632 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Federal Office for Safety in Health Care; Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: Ethics Committee; Greece: National Organization of Medicines; Italy: Ministry of Health; Mexico: Federal Commission for Sanitary Risks Protection; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Poland: Ethics Committee; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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 February 09, 2010