Study to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Prostatic Hyperplasia

Treatments: Drug: Finasteride; Drug: Placebo; Drug: Tamsulosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02244229

527.15

Details and patient eligibility

About

Study to evaluate the therapeutic effect of tamsulosin and finasteride in symptomatic BPH patients, two medications indicated in BPH belonging to two different pharmacological classes, as evaluated from the point of view of patient's perception of his pathological condition and of the impact of the disease on general health and quality of life

Enrollment: 403 patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male out-patients aged 50-80 years
• IPSS >= 13 at Visit 1
• Qmax: 4-15 ml/sec at Visit 2
• Residue urinary volume > 400 ml as evaluated by ultrasonography
• SPI >= 7 at Visit 2
• Prostate Specific Antigen (PSA) value < 3 ng/ml at Visit 1, or of 3-10 ng/ml provided that prostate cancer is ruled out on the basis of the usual diagnostic procedures performed at each Centre
• Written informed consent

Exclusion criteria

Patients with known history or diagnosis at the time of the screening visit of the following conditions that could influence the end-points of the study:

• Urological disturbances

  • Medical history of pelvic surgery; palpable bladder at the physical examination, or residue urinary volume > 400 ml; known neurological bladder disorder, bladder neck stenosis, urethral stricture, bladder or prostatic cancer, bladder stone, severe diverticulum of the bladder, symptomatic urinary tract infection during the last month, or recurrent urinary tract infections (more than 2 during the last year); hematuria of unknown origin; diseases that may affect micturition (e.g. diabetes mellitus)

• Cardiovascular diseases - The following cardiovascular diseases if occurred in the last 6 months:

  • Myocardial infarction
  • Unstable angina
  • Clinically significant ventricular arrhythmias
  • Heart failure (NYHA classes III/IV)
  • Orthostatic hypotension
  • Cerebral stroke

• Neurological diseases

  • such as senile dementia, multiple sclerosis, Parkinson's disease, psychiatric disturbances, if their severity could have prevented the correct performance of the trial

• Hepatic or renal insufficiency

  • (Biochemistry values 15% outside normal laboratory ranges and regarded as clinically relevant by investigator)

• Clinically significant abnormalities in the results of hematologic and biochemical tests performed on blood samples drawn at the screening visit

• Patients who are taking or have been taking α-blockers for BPH or for hypertension or phytotherapy for BPH in the previous 6 weeks

• Patients who are taking or have been taking finasteride in the last 6 months

• Patients who require concomitant drugs which could influence the pharmacodynamic or pharmacokinetic properties of tamsulosin. In particular: alpha-blockers and mixed alpha-beta blockers, alpha- agonists, anti-cholinergics

• Patient who are or have been taking part in a clinical study in the previous 3 months

• Patients who have hypersensitivity or allergic reactions to previously prescribed alpha-blocker(s) or to finasteride

• Patients judged by the investigator to be inappropriate for inclusion in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

403 participants in 2 patient groups

Tamsulosin

Experimental group

Treatment:

Drug: Placebo

Drug: Tamsulosin

Finasteride

Active Comparator group

Treatment:

Drug: Placebo

Drug: Finasteride