Benign Prostatic HyperplasiaPhase 3NCT00861757
Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia
A Phase 3 study testing Tadalafil and Tamsulosin in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 6 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Tadalafil and Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 612 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Mar 2009to Jun 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asian males, with benign prostatic hyperplasia (BPH) 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, erectile dysfunction (ED) and overactive bladder (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
Who cannot join
- Prostate specific antigen (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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Japan3 sites
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.
Hyōgo, 663-8006
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.
Osaka, 565-0854
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.
Tokyo, 130-0026
Taiwan3 sites
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.
Kaohsiung City, 813
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.
Taipei, 100
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.
Taoyuan, 333
About this 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
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).
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Tadalafil, Placebo, Tamsulosin
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TadalafilDrug
Also called LY450190, Cialis
by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
PlaceboDrug
PO, QD (30 min after meal) for 12 weeks
TamsulosinDrug
PO, QD (30 min after meal) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| 2.5 mg Tadalafil | Experimental | Not described Receives: Drug: Tadalafil |
| 5.0 mg Tadalafil | Experimental | Not described Receives: Drug: Tadalafil |
| 0.2 mg Tamsulosin | Active comparator | Not described Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.
Measured: baseline, 12 weeks
Secondary outcomes (11)
Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive])
IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms); 4 questions of the obstructive score range from 0 to 20. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms); 3 questions of the irritative subscore range from 0 to 15. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.
Measured: baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks
Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible).
Least Squares Mean values were controlled for Benign Prostatic Hyperplasia severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.
Measured: baseline, 12 weeks
Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks
The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least Squares Mean values were controlled for BPH severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.
Measured: baseline, 12 weeks
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks
Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter).
Least Squares Mean values were controlled for Benign Prostatic Hyperplasia (BPH) severity (moderate/severe), prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan), and baseline value.
Measured: baseline, 12 weeks
Patient Global Impression of Improvement (PGI-I) at Week 12
The PGI-I measures the patient's perception of improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).
Measured: 12 weeks
Clinician Global Impression of Improvement (CGI-I) at Week 12
The CGI-I measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. There are 7 categories with scores ranging from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the 7 categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7).
Measured: 12 weeks
Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks
Nanograms of PSA per milliliter (ng/mL) of blood.
Measured: baseline, 12 weeks
Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks
The PVR is defined as the volume of urine remaining in the bladder after voiding, estimated by ultrasound.
Measured: baseline, 12 weeks
Change From Baseline in Blood Pressure (Sitting) at 12 Weeks
Measured: baseline, 12 weeks
Change From Baseline in Blood Pressure (Standing) at 12 Weeks
Measured: baseline, 12 weeks
Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861757
- Sponsor's protocol ID
- 10487
- Other IDs
- H6D-MC-LVHB
- Status last verified
- Jun 2011
- First submitted
- 12 Mar 2009
- Last updated
- 28 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00861757
- Acronym / sponsor ID
- 10487
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 612 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Posted 13 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| 2.5 mg Tadalafil | Experimental | Drug: Tadalafil |
| 5.0 mg Tadalafil | Experimental | Drug: Tadalafil |
| 0.2 mg Tamsulosin | Active comparator | Drug: Tamsulosin |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Asian males, with benign prostatic hyperplasia (BPH) 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, erectile dysfunction (ED) and overactive bladder (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
Key exclusion criteria (8 listed)
- Prostate specific antigen (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TadalafilAlso: LY450190, Cialisby mouth (PO), once daily (QD) (30 min after meal) for 12 weeks | Drug | 2.5 mg Tadalafil, 5.0 mg Tadalafil |
| PlaceboPO, QD (30 min after meal) for 12 weeks | Drug | Placebo |
| TamsulosinPO, QD (30 min after meal) for 12 weeks | Drug | 0.2 mg Tamsulosin |
Primary outcome
Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks
Time frame: baseline, 12 weeks
The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares Mean values were controlled for prior alpha blocker use (yes/no), country (Japan/Korea/Taiwan) and baseline value.
11 secondary outcomes
Change From Baseline to 12 Weeks in International Prostate Symptom Score (IPSS) Subscore (Storage [Irritative] and Voiding [Obstructive])
Time frame: baseline, 12 weeks
Change From Baseline in International Prostate Symptom Score (IPSS) Quality of Life (QoL) at 12 Weeks
Time frame: baseline, 12 weeks
Change From Baseline in Benign Prostatic Hyperplasia (PBH) Impact Index (BII) at 12 Weeks
Time frame: baseline, 12 weeks
Change From Baseline in Uroflowmetry Parameter: Peak Flow Rate (Qmax) at 12 Weeks
Time frame: baseline, 12 weeks
Patient Global Impression of Improvement (PGI-I) at Week 12
Time frame: 12 weeks
Clinician Global Impression of Improvement (CGI-I) at Week 12
Time frame: 12 weeks
Change From Baseline in Prostate Specific Antigen (PSA) at 12 Weeks
Time frame: baseline, 12 weeks
Change From Baseline in Postvoid Residual Volume (PVR) at 12 Weeks
Time frame: baseline, 12 weeks
Change From Baseline in Blood Pressure (Sitting) at 12 Weeks
Time frame: baseline, 12 weeks
Change From Baseline in Blood Pressure (Standing) at 12 Weeks
Time frame: baseline, 12 weeks
Change From Baseline in Sitting Heart Rate (HR) at 12 Weeks
Time frame: baseline, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tadalafil and Tamsulosin in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks (time frame: baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.