A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia - LVHK

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-004321-15-PT
• Date of registration: 18/10/2007
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company Limited
• Public title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia - LVHK
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia - LVHK
• Date of first enrolment: 14/12/2007
• Target sample size: 190
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004321-15
• 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: no Placebo: yes Other: no

Countries of recruitment

Portugal

Key inclusion & exclusion criteria

Inclusion criteria:
[1] Present with BPH LUTS based on the disease diagnostic criteria at Visit 1.
[2] Are men 45 years of age or older at Visit 1.
[3] Provide signed informed consent document at Visit 1.
[4] Agree not to use any other approved or experimental pharmacologic treatments for BPH LUTS, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study.
[5] Have not taken the following treatments within the indicated duration:
[a] Finasteride or dutasteride therapy for at least 4 months prior to Visit 2.
[b] All other LUTS therapy (including herbal preparations) for at least 4 weeks prior to Visit 2.
[c] Any PDE5 inhibitor for at least 4 weeks prior to Visit 2.
[6] Have LUTS with a total IPSS greater than or equal to 13 under 1 of the following conditions:
[a] At Visit 1 if the subject does not require wash out of therapy for BPH LUTS.
[b] At Visit 2 if the subject requires wash out (4 weeks) of BPH LUTS therapy.

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:
[1] PSA >10.0 ng/mL at Visit 1.
[2] PSA of 4.0 to 10.0 ng/mL inclusive at Visit 1 without documentation of a histologic biopsy of the prostate negative for cancer within 12 months of Visit 1.
[3] PVR measurement by ultrasound greater than or equal to 350 mL at Visit 1.
[4] 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 on the urinary tract.
[d] Lower urinary tract malignancy or trauma.
[e] Chronic pelvic pain syndrome.
[5] Lower urinary tract instrumentation within 30 days of Visit 1.
[6] Any history of urinary retention or lower urinary tract stones within 6 months of Visit 1.
[7] History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
[8] Clinical evidence or history of any of the following bladder conditions:
[a] Bladder calculi.
[b] Intravesical obstruction.
[c] Atonic, decompensated, or hypocontractile bladder.
[d] Detrusor-sphincter dyssynergia.
[e] Interstitial cystitis.
[9] Evidence of any of the following urinary tract conditions:
[a] Urinary tract infection (UTI), defined as a positive urine culture at Visit 1, or a UTI that is not resolved at repeat testing following a course of antibiotic therapy.
[b] Urinary tract inflammation at Visit 1, defined as a positive result for leukocyte esterase from a urine dipstick or >5 white blood cells (WBC) per high powered field on urinalysis from a centrifuged, clean-catch, midstream urine specimen.
[c] Current antibiotic therapy for UTI at Visit 1.
[10] Clinical evidence of prostate cancer.
[11] Current neurologic disease or condition associated with neurogenic bladder.
[12] History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance <50 mL/min at Visit 1 as calculated by the central laboratory using the Cockroft-Gault formula:
(140 - age [years]) × weight [kg] / (72 × serum creatinine [mg/dL])
[13] Active symptomatic hepatobiliary disease at Visit 1.
[14] 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.
[15] 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.
[16] Evidence of heart disease categorized as NYHA above or including Class III within 6 months of Visit 1.
[17] Systolic blood pressure >160 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at Visit 1 (if stress is suspected, retest under basal conditions), or malignant hypertension.
[18] Scheduled or planned surgery (or any procedure requiring general, spinal, or epidural anesthesia) during the course of the study.
[19] History of significant central nervous system (CNS) injuries within 6 months of Visit 1.
[20] History of drug, alcohol, or substance abuse within 6 months of Visit 1.
[21] 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 interp

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

Health Condition(s) or Problem(s) studied

Effects on urodynamic parameters in men with benign prostatic hyperplasia (also referred to as BPH-LUTS [lower urinary tract symptoms]) with and without urodynamic evidence of bladder outlet obstruction. LUTS include urinary frequency, urgency, intermittency, nocturia, straining, incomplete emptying and weak urinary stream.
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: LY450190
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To compare the effect of tadalafil 20 mg once a day for 12 weeks on detrusor pressure at peak urinary flow rate versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms (BPH LUTS).

Primary end point(s): The primary endpoint is the detrusor pressure at maximum flow rate, which is measured during baseline and end of study urodynamics assessments.

Secondary Objective: To examine the effects of tadalafil 20 mg once a day for 12 weeks (compared with placebo) on the urodynamic parameters.

To assess the safety of tadalafil 20 mg once a day for 12 weeks in the treatment of men with BPH LUTS as examined by the following measures:
- Adverse events
- Clinical laboratory tests

To assess the efficacy of tadalafil 20 mg once a day for 12 weeks in the treatment of men with BPH LUTS as examined by the International Prostate Symptom Score (IPSS).

Secondary ID(s)

H6D-MC-LVHK(b)