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. - LVID

• Register: EUCTR
• Last refreshed on: 14 October 2013
• Main ID: EUCTR2009-010739-42-BE
• Date of registration: 07/09/2009
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public 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. - LVID
• 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. - LVID
• Date of first enrolment: 07/10/2009
• Target sample size: 453
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010739-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Austria, Belgium, France, Germany, Greece, Italy, Netherlands

Key inclusion & exclusion criteria

Inclusion criteria:
-Men 45 years of age or older at Visit 1.
-Provide signed informed consent at Visit 1.
-Agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments, including alpha blockers, 5-alpha reductase inhibitors (5-ARIs), antimuscarinics, phosphodiesterase type 5 (PDE5) inhibitors, or herbal preparations at any time during the study.
-Have not taken the following treatments within the indicated duration:
[a] Finasteride therapy for at least 3 months prior to Visit 2.
[b] Dutasteride therapy for at least 6 months prior to Visit 2.
[c] Other BPH therapy (including herbal preparations) for at least
4 weeks prior to Visit 2.
[d] OAB therapy for at least 4 weeks prior to Visit 2.
[e] ED therapy for at least 4 weeks prior to Visit 2.
[f] Other experimental or off-label BPH therapy, such as injectable therapies with a protracted effect, for at least 1/2 year prior to Visit 2.
-Have LUTS with a Total IPSS >=13 at Visit 2.
-Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of >=4 to =<15 mL/second (from a prevoid total bladder volume [assessed by ultrasound] of >=150 to=<550 mL and a minimum voided volume of 125 mL) at Visit 2.
-Demonstrate compliance with study drug administration requirements during the placebo lead-in period by administering >=70% of prescribed doses, confirmed by documentation that the subject returned <=30% of prescribed doses at Visit 3.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
-PSA >10.0 ng/mL at Visit 1.
-PSA >=4.0 to <=10.0 ng/mL at Visit 1 if prostate malignancy has not been ruled out to the satisfaction of an urologist.
-Bladder PVR >=300 mL by ultrasound determination at Visit 1.
-History of any of the following pelvic conditions:
[a] Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or bowel resection.
[b] Pelvic radiotherapy.
[c] Any pelvic surgical procedure of the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery.
[d] Lower urinary tract malignancy or trauma.
-Lower urinary tract instrumentation within 30 days of Visit 1.
-History of urinary retention or lower urinary tract stones within 6 months of Visit 1.
-History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
-Clinical evidence of any of the following bladder conditions:
[a] Mullerian duct cysts.
[b] Atonic, decompensated, or hypocontractile bladder.
[c] Detrusor-sphincter dyssynergia.
[d] Intravesical obstruction.
[e] Interstitial cystitis.
-Clinical evidence of any of the following urinary tract conditions at Visit 1:
[a] Urinary tract infection.
[b] Urinary tract inflammation.
[c] Current antibiotic therapy for urinary tract infection.
[d] Clinically significant microscopic hematuria as determined by a urologist.
-Clinical evidence of prostate cancer.
-Current neurologic disease or condition associated with neurogenic bladder.
-History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance <30 mL/minute at Visit 1 as calculated by the central laboratory using the Cockroft-Gault Formula.
-Clinical evidence of severe hepatic impairment at Visit 1.
-History of any of the following cardiac conditions:
[a] Angina requiring treatment with long-acting nitrates.
[b] Angina requiring treatment with short-acting nitrates within 90 days of Visit 1.
[c] Unstable angina within 90 days of Visit 1.
[d] Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention.
-History of any of the following coronary conditions within 90 days of Visit 1:
[a] Myocardial infarction.
[b] Coronary artery bypass graft surgery.
[c] Percutaneous coronary intervention.
-Any evidence of heart disease (New York Heart Association [NYHA] >=Class III within 6 months of Visit 1.
-Systolic blood pressure >160 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at Visit 1, or malignant hypertension.
-Scheduled or planned surgery during the course of the study.
-Scheduled or planned cataract surgery during the course of the study due to risk of intraoperative floppy iris syndrome (IFIS).
-History of significant central nervous system injuries within 6 months of Visit 1.
-History of drug, alcohol, or substance abuse within 6 months of Visit 1.
-Any condition that would interfere with subject ability to provide informed consent or comply with study instructions, would place subject at increased risk, or might confound the interpretation of the study results.
-Current treatment with nitrates, androgens, antiandrogens, estrogens, luteinizing
hormone-releasing hormone agonists/antagonists, or anabolic steroids.
-Current systemic treatment with any of the following:
[a] Potent cytochrome P450 3A4 (CYP3A4) inhibitors, such as ketoconazole or ritonavir.
[b] Potent CYP3A4 inducer, such as rifampicin.
-Glycosylated hemoglobin (HbA1c) >9% at Visit 1.
-Known

Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Benign Prostatic Hyperplasia (BPH)
MedDRA version: 9.1 Level: LLT Classification code 10004446 Term: Benign prostatic hyperplasia

Intervention(s)

Trade Name: Cialis
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tadalafil
CAS Number: 171596-29-5
Current Sponsor code: 450190
Other descriptive name: TADALAFIL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Omnic MR
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: TAMSULOSIN HYDROCHLORIDE
CAS Number: 106463176
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.4-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To evaluate the efficacy of tadalafil 5 mg once daily for 12 weeks compared with placebo in improving the IPSS in men with signs and symptoms of BPH, also referred to as BPH-LUTS (lower urinary tract symptoms).

Primary end point(s): Change in IPSS from baseline after 12 weeks.

Secondary Objective: To evaluate the:
-efficacy of tamsulosin 0.4 mg daily compared with placebo in improving IPSS in men with BPH-LUTS.
-efficacy of tadalafil 5 mg daily compared with placebo and tamsulosin 0.4 mg daily compared with placebo for in the treatment of men with BPH-LUTS.
-efficacy of tadalafil 5 mg daily compared with placebo and tamsulosin 0.4 mg daily compared with placebo after 1 week and 4 weeks of treatment in men with BPH-LUTS as assessed by the modified IPSS (mIPSS).
-efficacy of tadalafil 5 mg daily compared with placebo and tamsulosin 0.4 mg daily compared with placebo of treatment in men with BPH-LUTS and ED as assessed by the IIEF-EF Domain.
-effect of tadalafil 5 mg daily compared with placebo and tamsulosin 0.4 mg daily compared with placebo in the treatment of men with BPH-LUTS as assessed by uroflowmetry measurements.
-safety of tadalafil 5 mg daily and tamsulosin 0.4 mg daily in the treatment of men with BPH-LUTS.

Secondary ID(s)

2009-010739-42-DE

H6D-MC-LVID