A randomized, double-blind, placebo-controlled, multi-center, parallel group study to assess the efficacy of vardenafil in the treatment of symtomatic Benign Prostatic Hyperplasia

• Register: EUCTR
• Last refreshed on: 10 February 2014
• Main ID: EUCTR2005-002796-32-DE
• Date of registration: 21/10/2005
• Prospective Registration: No
• Primary sponsor: Bayer Healthcare AG
• Public title: A randomized, double-blind, placebo-controlled, multi-center, parallel group study to assess the efficacy of vardenafil in the treatment of symtomatic Benign Prostatic Hyperplasia
• Scientific title: A randomized, double-blind, placebo-controlled, multi-center, parallel group study to assess the efficacy of vardenafil in the treatment of symtomatic Benign Prostatic Hyperplasia
• Date of first enrolment: 17/10/2005
• Target sample size: 280
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002796-32
• 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

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
At SCREENING
- Males 45 to (including) 64 years of age
- Lower urinary tract symptoms (LUTS) for >= 6 months
- Documented, signed and dated written Informed Consent

At RANDOMIZATION
- IPSS total score >= 12

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) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
At SCREENING

A) Previous or Current Medical Conditions

- Any unstable medical, psychiatric, or substance abuse disorder that, in the opinion
of the investigator, is likely to affect the subject's ability to complete the study or
precludes the subject’s participation in the study
- Spinal cord injury
- Hereditary degenerative retinal disorders such as retinitis pigmentosa
- History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C
- Severe chronic or acute liver disease, including history of moderate (Child-Pugh B)
or severe (Child-Pugh C) hepatic impairment
- Clinically significant chronic hematological disease which may lead to priapism
such as sickle cell anemia, multiple myeloma or leukemia
- Clinically significant bleeding disorder
- Significant active peptic ulceration
- Prostatitis (chronic or current)
- Known vesical tumors (benign or malign)
- History of prostate cancer
- Clinically significant stricture of bladder or urethra
- History of or current urinary retention
- History of clinically significant pelvic trauma or surgery
- Known stones or concrements in the urinary tract
- Neurological diseases or symptoms that may interfere with voiding
- Any underlying cardiovascular condition including unstable angina pectoris
that would preclude sexual activity
- History of myocardial infarction, stroke, or life-threatening arrhythmia
within the prior 6 months
- Uncontrolled atrial fibrillation/flutter at screening
(ventricular response rate > 100 bpm)
- Current macro-hematuria
- Resting hypotension (a resting systolic blood pressure of <90 mm Hg)
or hypertension (a resting systolic blood pressure >170 mm Hg
or a resting diastolic blood pressure >110 mm Hg)
- Symptomatic postural hypotension within 6 months of Visit 1
- History of malignancy within the past 5 years (other than squamous or basal cell skin cancer)
- Life expectancy <3 years
- Previous episode of non arteritic ischemic optic neuropathy (NAION)

B) Concomitant Medication

- Nitrates or nitric oxide donors
- Oral, injectable or trans-dermal androgens
- Anti-androgens
- Any of the following potent inhibitors of cytochrome P- 450 3A4:
. HIV protease inhibitors such as ritonavir or indinavir;
. anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed);
. erythromycin
- Any investigational drug (including placebo) within 30 days of Visit 1
- Any treatment for ED other than study medication during the study,
including oral medications, vacuum devices, constrictive devices, injections
or urethral suppositories
- Alpha1 adrenoceptor antagonists (alpha blockers) during entire course of the study
- Previous or current use of inhibitors of 5-alpha-reductase
(e.g. finasteride, dutasteride).

C) Abnormal Laboratory Values

- PSA >= 3 ng/ml
- Creatinine Clearance < 30 mL/min
- Elevation of AST and/or ALT >= 3 x the Upper Limit of Normal
- Micro-hematuria (assessment by means of dipsticks)

D) Other Exclusions

- Known hypersensitivity to vardenafil, Bay 38-9456 (also known as SB-782528)
or any component of the investigational medication
- Illiterate or are unable to understand the questionnaires
- Unwilling or unable to complete the questionnaires

At RANDAMIZATION
- All SCREENING Exclusion Criteria
- Residual urine volume > 100 mL (sonographic assessment)
- Micro- or macro-hematuria
- If alpha-blockers were withdrawn at Visit 1 (Screening):
significant (in the opinion of the investigato

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

Health Condition(s) or Problem(s) studied

Benigne Prostatic Hyperplasia
MedDRA version: 8.0 Level: LLT Classification code 10004446

Intervention(s)

Trade Name: Levitra 10 mg Filmtabletten
Product Name: Levitra 10 mg Filmtabletten
Product Code: Bay 38-9456
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Vardenafil-HCL
CAS Number: 224785-91-5
Current Sponsor code: BAY 38-9456 / SB-782528
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To assess the efficacy, tolerability and safety of vardenafil (10 mg BID) versus placebo in the two month treatment of men with symptomatic BPH.

Secondary Objective: Secondary variables of efficacy are
- the Post-void residual urine volume (PVR),
- the Quality-of-life questionnaire 9 (QoL-9) and
- the erectile function domain of the International Index of Erectile Function (IIEF-EF).

Primary end point(s): Primary endpoints of efficacy are
- the International Prostate Symptoms Score (IPSS) and
- the maximum urinary flow (Q max)
which will be tested in a hierarchical order.

Secondary ID(s)

BAY 38-9456 / 11863