A Study of Tadalafil (LY450190) in Participants With Benign Prostatic Hyperplasia (BPH)
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia
Intervention: Tadalafil (Drug); Placebo (Drug); Alpha1 Blocker (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): 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, Affiliation: Eli Lilly and Company
Overall contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559
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.
Clinical Details
Official title: A Post-Marketing Clinical Study of LY450190 (Combined With Alpha1 Blocker Treatment)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Proportion of Participants Preferring Combination Therapy over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ)
Secondary outcome: Change from Baseline on the International Prostate Symptom Score (IPSS) Total ScoreChange from Baseline on the IPSS Storage (Irritative) Subscore Change from Baseline on the IPSS Voiding (Obstructive) Subscore Change from Baseline on the IPSS Quality of Life Score Patient Global Impression of Improvement (PGI-I) PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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:
- 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
Exclusion Criteria:
- 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
- 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
Locations and Contacts
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559
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, Japan; Recruiting Eli Lilly and Company
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, Japan; Recruiting Eli Lilly and Company
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, Japan; Recruiting Eli Lilly and Company
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, Japan; Recruiting Eli Lilly and Company
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, Japan; Recruiting Eli Lilly and Company
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, Japan; Recruiting Eli Lilly and Company
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, Japan; Recruiting Eli Lilly and Company
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, Japan; Recruiting Eli Lilly and Company
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, Japan; Recruiting Eli Lilly and Company
Additional Information
Starting date: April 2015
Last updated: May 14, 2015
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