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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00970632




Registration number
NCT00970632
Ethics application status
Date submitted
1/09/2009
Date registered
2/09/2009
Date last updated
12/03/2012

Titles & IDs
Public title
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia
Scientific 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
Secondary ID [1] 0 0
H6D-MC-LVID
Secondary ID [2] 0 0
12932
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia (BPH) 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tadalafil 5 mg
Treatment: Drugs - Placebo tablet
Treatment: Drugs - Tamsulosin
Treatment: Drugs - Placebo capsule

Placebo comparator: Placebo - Placebo tablet with tamsulosin dose orally (po) once daily (QD) and placebo capsule with tadalafil dose po QD for 12 weeks

Experimental: Tadalafil 5 milligram (mg) - Tadalafil 5 mg tablet po QD and placebo capsule po QD for 12 weeks

Active comparator: Tamsulosin 0.4 mg - Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks


Treatment: Drugs: Tadalafil 5 mg
Tadalafil 5 mg po QD for 12 weeks

Treatment: Drugs: Placebo tablet
Placebo tablet po QD for 12 weeks

Treatment: Drugs: Tamsulosin
Tamsulosin 0.4 mg po QD for 12 weeks

Treatment: Drugs: Placebo capsule
Placebo capsule po QD for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks
Timepoint [1] 0 0
Baseline, 12 weeks
Secondary outcome [1] 0 0
Change From Baseline in Total International Prostate Symptom Score (IPSS) at 4 Weeks
Timepoint [1] 0 0
Baseline, 4 weeks
Secondary outcome [2] 0 0
Change From Baseline in International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore at 12 Weeks
Timepoint [2] 0 0
Baseline, 12 weeks
Secondary outcome [3] 0 0
Change From Baseline in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore at 12 Weeks.
Timepoint [3] 0 0
Baseline, 12 weeks
Secondary outcome [4] 0 0
Change From Baseline in International Prostate Symptom Score (IPSS) Nocturia Question at 12 Weeks
Timepoint [4] 0 0
Baseline, 12 weeks
Secondary outcome [5] 0 0
Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index at 12 Weeks
Timepoint [5] 0 0
Baseline, 12 weeks
Secondary outcome [6] 0 0
Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at 1 Week
Timepoint [6] 0 0
Baseline, 1 week
Secondary outcome [7] 0 0
Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 4 Weeks
Timepoint [7] 0 0
Baseline, 4 weeks
Secondary outcome [8] 0 0
Change From Baseline in Benign Prostatic Hyperplasia Impact Index (BII) at 12 Weeks
Timepoint [8] 0 0
Baseline, 12 weeks
Secondary outcome [9] 0 0
Patient Global Impression of Improvement (PGI-I) at 12 Weeks
Timepoint [9] 0 0
12 weeks
Secondary outcome [10] 0 0
Clinician Global Impression of Improvement (CGI-I) at 12 Weeks
Timepoint [10] 0 0
12 weeks
Secondary outcome [11] 0 0
Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 12 Weeks: Overall
Timepoint [11] 0 0
12 weeks
Secondary outcome [12] 0 0
Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at 12 Weeks
Timepoint [12] 0 0
Baseline, 12 weeks
Secondary outcome [13] 0 0
Change From Baseline in Peak Urine Flow Rate (Q-Max) at 12 Weeks
Timepoint [13] 0 0
Baseline, 12 weeks
Secondary outcome [14] 0 0
Change From Baseline in Mean Urine Flow Rate (Q-Mean) at 12 Weeks
Timepoint [14] 0 0
Baseline, 12 weeks
Secondary outcome [15] 0 0
Change From Baseline in Volume of Voided Urine (V-Comp) at 12 Weeks
Timepoint [15] 0 0
Baseline, 12 weeks
Secondary outcome [16] 0 0
Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks
Timepoint [16] 0 0
Baseline, 12 weeks

Eligibility
Key inclusion criteria
* Men 45 years of age or older with benign prostatic hyperplasia (BPH) also referred to as BPH-lower urinary tract symptoms (LUTS) 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 special toilet equipment).
* Demonstrate compliance with study drug administration requirements.
Minimum age
45 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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 nanograms per milliliter (ng/mL) at the start of study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
Accrual to date
Final
511
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
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. - Adelaide
Recruitment hospital [2] 0 0
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. - Bentleigh East
Recruitment hospital [3] 0 0
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. - Bunbury
Recruitment hospital [4] 0 0
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. - Nedlands
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [3] 0 0
6230 - Bunbury
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Salzburg
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Belgium
State/province [5] 0 0
Liege
Country [6] 0 0
France
State/province [6] 0 0
Garches
Country [7] 0 0
France
State/province [7] 0 0
Nice
Country [8] 0 0
France
State/province [8] 0 0
Orleans
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
France
State/province [10] 0 0
Pierre Benite
Country [11] 0 0
France
State/province [11] 0 0
Suresnes
Country [12] 0 0
Germany
State/province [12] 0 0
Bad Rappenau
Country [13] 0 0
Germany
State/province [13] 0 0
Bad Wiessee
Country [14] 0 0
Germany
State/province [14] 0 0
Hannover
Country [15] 0 0
Germany
State/province [15] 0 0
Leipzig
Country [16] 0 0
Germany
State/province [16] 0 0
Marburg
Country [17] 0 0
Germany
State/province [17] 0 0
Muehlacker
Country [18] 0 0
Germany
State/province [18] 0 0
Oranienburg
Country [19] 0 0
Greece
State/province [19] 0 0
Heraklion
Country [20] 0 0
Greece
State/province [20] 0 0
Ioannina
Country [21] 0 0
Greece
State/province [21] 0 0
Larissa
Country [22] 0 0
Greece
State/province [22] 0 0
Patras
Country [23] 0 0
Greece
State/province [23] 0 0
Thessaloniki
Country [24] 0 0
Italy
State/province [24] 0 0
Bergamo
Country [25] 0 0
Italy
State/province [25] 0 0
Cagliari
Country [26] 0 0
Italy
State/province [26] 0 0
Firenze
Country [27] 0 0
Italy
State/province [27] 0 0
Napoli
Country [28] 0 0
Italy
State/province [28] 0 0
Sassari
Country [29] 0 0
Mexico
State/province [29] 0 0
Monterrey
Country [30] 0 0
Mexico
State/province [30] 0 0
Morelia
Country [31] 0 0
Mexico
State/province [31] 0 0
Saltillo
Country [32] 0 0
Mexico
State/province [32] 0 0
Zapopan
Country [33] 0 0
Netherlands
State/province [33] 0 0
Arnhem
Country [34] 0 0
Netherlands
State/province [34] 0 0
Breda
Country [35] 0 0
Netherlands
State/province [35] 0 0
S-Hertogenbosch
Country [36] 0 0
Netherlands
State/province [36] 0 0
Tilburg
Country [37] 0 0
Netherlands
State/province [37] 0 0
Veldhoven
Country [38] 0 0
Poland
State/province [38] 0 0
Bialystok
Country [39] 0 0
Poland
State/province [39] 0 0
Kutno
Country [40] 0 0
Poland
State/province [40] 0 0
Warsaw

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00970632