Benign Prostatic HyperplasiaPhase 4NCT02431754
A Study of Tadalafil (LY450190) in Participants With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia LUTS (BPH-LUTS).
A Phase 4 study testing Tadalafil and Alpha1 Blocker in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 9 sites in Japan.
Trial summary
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as tadalafil in participants with benign prostatic hyperplasia who are being treated with an alpha1 blocker. This study has two treatment periods. Participants will receive tadalafil or placebo in each treatment period. 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 Alpha1 Blocker
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 9 sitesJapan
- Study dates
- Apr 2015to Feb 2016
- Phase
- Phase 4
- 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
- Present with benign prostatic hyperplasia (BPH; also referred to as BPH-LUTS), based on the disease diagnostic criteria, at study entry.
- Have been treated with a stable dose of an alpha1 blocker (tamsulosin 0.2 mg once daily or silodosin 4 mg twice daily) for at least 8 weeks prior to screening, and continue the same alpha1 blocker at the same dose for the entire duration of the study.
- Are Japanese men.
- Have prostate volume ≥20 milliliters (mL) estimated by transabdominal or transrectal ultrasound at screening.
- Have BPH-LUTS with a Total International Prostate Symptom Score (IPSS) of ≥12 at screening and baseline.
- Have moderate LUTS with urinary peak flow rate (Qmax) ≥4 to ≤15 mL/second at baseline, while meeting both of the following criteria:
Show all 11Show fewer
- Prevoid total bladder volume ≥150 to ≤550 mL as assessed by ultrasound
- Minimum voided volume ≥125 mL
- Demonstrate ≥80% compliance with alpha1 blocker treatment* during the screening period, documented at baseline
- *Tamsulosin: (Number of doses taken / Number of days to be treated) × 100
- Silodosin: (Number of doses taken / Number of days to be treated) × 50
Who cannot join
- Prostate-specific antigen (PSA) >10.0 nanograms (ng)/mL at screening.
- PSA ≥4.0 to ≤10.0 ng/mL at screening if prostate malignancy has not been ruled out to the satisfaction of a urologist.
- Bladder post-void residual (PVR) ≥150 mL by ultrasound determination at screening.
- History of any of the following pelvic conditions:
- Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or bowel resection
- Pelvic radiotherapy
Show all 48Show fewer
- Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery
- Lower urinary tract malignancy or trauma
- Lower urinary tract instrumentation (including prostate biopsy) within 30 days of screening.
- History of urinary retention or lower urinary tract (bladder) stones within 6 months of screening.
- History of urethral obstruction due to stricture, valves, sclerosis, or tumor at screening.
- History of any of the following treatments within the indicated duration:
- Antiandrogens within 11 months before screening
- Dutasteride within 5 months before screening
- Finasteride within 2 months before screening
- Any erectile dysfunction treatment previously or currently
- Any overactive bladder treatment within 4 weeks before screening
- Have a diagnosis or history of prostate cancer at screening.
- Current or history of malignancy at screening (except for treatment-free and relapse-free for ≥3 years at screening).
- Clinical evidence or history of any of the following bladder conditions:
- Underactive Bladder
- Detrusor-sphincter dyssynergia (contraction of the detrusor without sphincter relaxation)
- Interstitial cystitis
- Clinical evidence of any of the following urinary tract conditions:
- Active urogenital infection
- Clinically significant microscopic hematuria as determined by a urologist
- History of significant renal insufficiency meeting either of the following:
- Receiving renal dialysis
- Creatinine clearance (CLcr) <30 mL/minute
- Clinical evidence of severe hepatic impairment or Aspartate Transaminase (AST) or Alanine Transaminase (ALT) >3 times the upper limit of normal range.
- History of any of the following cardiac conditions:
- Current or history of angina requiring treatment with nitrates or nitric oxide donors
- Current or history of unstable angina
- Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention (e.g., coronary angioplasty)
- History of any of the following coronary conditions within 90 days of screening:
- Myocardial infarction
- Coronary artery bypass graft surgery
- Percutaneous coronary intervention (for example, angioplasty or stent placement)
- Any evidence or history of heart failure (New York Heart Association [NYHA] ≥ Class III).
- Currently receiving alpha1 blocker therapy for the treatment of hypertension.
- Current or history of any of the following symptoms:
- Symptoms associated with orthostasis (e.g., recurrent episodes of dizziness, lightheadedness, loss of consciousness, syncope)
- Causeless fall within 1 year of screening
- Blood pressure-related findings of any of the following at screening:
- Systolic blood pressure >160 or <90 millimeters of mercury (mm Hg)
- Diastolic blood pressure >100 or <50 mm Hg
- Malignant hypertension
- Uncontrolled arrhythmia
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 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.
Kyoto, 604-8436
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.
Maebashi, 371-0805
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, 542-0073
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.
Sagamihara, 252-0303
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.
Sakai, 590-0024
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.
Suita, 565-0874
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.
Takasaki, 370-0826
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.
Takatsuki, 569-1115
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, 132-0011
About this study
Official title: A Post-Marketing Clinical Study of LY450190 (Combined With Alpha1 Blocker Treatment)
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as tadalafil in participants with benign prostatic hyperplasia who are being treated with an alpha1 blocker. This study has two treatment periods. Participants will receive tadalafil or placebo in each treatment period.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Tadalafil, Placebo, Alpha1 Blocker
- 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
Administered orally
PlaceboDrug
Administered orally
Alpha1 BlockerDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil | Experimental | 5 milligrams (mg) tadalafil administered once daily orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods. Receives: Drug: Tadalafil; Drug: Alpha1 Blocker |
| Placebo | Placebo comparator | Placebo administered once daily orally for 8 weeks in one of two treatment periods.
0.2 mg tamulosin once daily or 4 mg silodosin twice daily.
Participants will remain on stable dose of alpha1 blocker through both treatment periods. Receives: Drug: Placebo; Drug: Alpha1 Blocker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Preferring Combination Therapy Over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ)
TPQ was used to investigate participant's preference between alpha1 blocker monotherapy and combination therapy with alpha1 blocker plus tadalafil. At the end of Treatment Period 2 (or discontinuation), participants were asked to choose a preferred treatment between the two treatments given in Treatment Period 1 and Treatment Period 2.
Measured: Week 20
Secondary outcomes (6)
Change From Baseline on the International Prostate Symptom Score (IPSS) Total Score
IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Measured: Baseline, Week 8
Change From Baseline on the IPSS Storage (Irritative) Subscore
IPSS Storage (Irritative) subscore was the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore ranging from 0 to 15. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Measured: Baseline,Week 8
Change From Baseline on the IPSS Voiding (Obstructive) Subscore
IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score ranging from 0 to 20. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.
Measured: Baseline, Week 8
Change From Baseline on the IPSS Quality of Life Score (IPSS QoL )
IPSS QoL assess participant response to the following question: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?". Response options are Delighted (0), Pleased (1); Mostly satisfied (2); mixed about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total ranging from 0 to 6 with higher numerical score representing worse Quality of Life from BPH symptom.
Measured: Baseline, Week 8
Percentage of Participants With Global Impression of Improvement (PGI-I)
The PGI I is a participant rated instrument that measures the improvement or worsening of the subject's symptoms based on a 7 point scale. A score of "1" indicates that the subject feels his symptoms are "very much better." A score of "4" indicates that the subjects feels "no change" in his symptoms and a score of "7" indicates that the subject feels his symptoms are "very much worse." The percentage of participants who reported a PGI-I score of 1 to 3 are presented in the table below.
Measured: Week 8
Percentage of Participants With PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms Improvement
PGI-I (Drug Attributes Questionnaire [DRAQ]) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms.The DRAQ includes the following urinary symptoms: 1. Difficulty to void; 2. Frequent nighttime voiding; 3. Feeling of incomplete emptying; 4. Frequent daytime voiding; 5. Urinary urgency; 6. Taking a long time to urinate; 7. Need abdominal pressure to void; 8. Dribbling, leakage, and/or accidents. Each urinary symptom in the DRAQ will be evaluated by a participant using the PGI-I (discrete variables with seven categories) at the end of each treatment period, compared with how the symptom was before the participant's began taking medication in this study. The percentage of participants who reported a PGI-I (Drug Attributes Questionnaire) score of 1 to 3 are presented in the table below.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2016
- Study completionFeb 2016
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nippon Shinyaku Co., Ltd.
- Responsible party
- Sponsor
- 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
- NCT02431754
- Sponsor's protocol ID
- 15734
- Other IDs
- H6D-JE-LVJK
- Status last verified
- Jun 2017
- First submitted
- 28 Apr 2015
- Last updated
- 2 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Marketing Clinical Study of LY450190 (Combined With Alpha1 Blocker Treatment)
- ClinicalTrials.gov ID
- NCT02431754
- Acronym / sponsor ID
- 15734
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Nippon Shinyaku Co., Ltd.
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Posted 1 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as tadalafil in participants with benign prostatic hyperplasia who are being treated with an alpha1 blocker. This study has two treatment periods. Participants will receive tadalafil or placebo in each treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tadalafil | Experimental | Drug: Tadalafil, Drug: Alpha1 Blocker5 milligrams (mg) tadalafil administered once daily orally for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily. Participants will remain on stable dose of alpha1 blocker through both treatment periods. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Alpha1 BlockerPlacebo administered once daily orally for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily. Participants will remain on stable dose of alpha1 blocker through both treatment periods. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Present with benign prostatic hyperplasia (BPH; also referred to as BPH-LUTS), based on the disease diagnostic criteria, at study entry.
- Have been treated with a stable dose of an alpha1 blocker (tamsulosin 0.2 mg once daily or silodosin 4 mg twice daily) for at least 8 weeks prior to screening, and continue the same alpha1 blocker at the same dose for the entire duration of the study.
- Are Japanese men.
- Have prostate volume ≥20 milliliters (mL) estimated by transabdominal or transrectal ultrasound at screening.
- Have BPH-LUTS with a Total International Prostate Symptom Score (IPSS) of ≥12 at screening and baseline.
Key exclusion criteria (48 listed)
- Prostate-specific antigen (PSA) >10.0 nanograms (ng)/mL at screening.
- PSA ≥4.0 to ≤10.0 ng/mL at screening if prostate malignancy has not been ruled out to the satisfaction of a urologist.
- Bladder post-void residual (PVR) ≥150 mL by ultrasound determination at screening.
- History of any of the following pelvic conditions:
- Lower urinary tract instrumentation (including prostate biopsy) within 30 days of screening.
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: LY450190Administered orally | Drug | Tadalafil |
| PlaceboAdministered orally | Drug | Placebo |
| Alpha1 BlockerAdministered orally | Drug | Placebo, Tadalafil |
Primary outcome
Percentage of Participants Preferring Combination Therapy Over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ)
Time frame: Week 20
TPQ was used to investigate participant's preference between alpha1 blocker monotherapy and combination therapy with alpha1 blocker plus tadalafil. At the end of Treatment Period 2 (or discontinuation), participants were asked to choose a preferred treatment between the two treatments given in Treatment Period 1 and Treatment Period 2.
6 secondary outcomes
Change From Baseline on the International Prostate Symptom Score (IPSS) Total Score
Time frame: Baseline, Week 8
Change From Baseline on the IPSS Storage (Irritative) Subscore
Time frame: Baseline,Week 8
Change From Baseline on the IPSS Voiding (Obstructive) Subscore
Time frame: Baseline, Week 8
Change From Baseline on the IPSS Quality of Life Score (IPSS QoL )
Time frame: Baseline, Week 8
Percentage of Participants With Global Impression of Improvement (PGI-I)
Time frame: Week 8
Percentage of Participants With PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms Improvement
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- 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
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tadalafil and Alpha1 Blocker in people with Benign Prostatic Hyperplasia, run by Eli Lilly and Company at 9 sites in Japan.
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 11 inclusion and 48 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 1 Mar 2017). 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?
Percentage of Participants Preferring Combination Therapy Over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ) (time frame: Week 20). 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 2 Jul 2017.