FLOMAX® Versus HYTRIN® in Patients With the Signs and Symptoms of Benign Prostatic Hyperplasia

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Prostatic Hyperplasia

Treatments

Drug: Ascending doses of HYTRIN® capsules

Drug: FLOMAX® capsules

Study type

Interventional

Funder types

Industry

Identifiers

NCT02244255

527.17

Details and patient eligibility

About

To study the early onset of symptomatic relief afforded by FLOMAX® capsules, 0.4 mg daily as compared to HYTRIN® capsules, 5 mg (with titration) daily in patients with the signs and symptoms of benign prostatic hyperplasia (BPH)
To evaluate patient's tolerability to the use of FLOMAX® capsules 0.4 mg daily in comparison to HYTRIN® capsules, 5 mg (with titration) daily for the treatment of the symptoms of benign prostatic hyperplasia

Enrollment

1,993 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male patients (45 years of age or older) diagnosed with benign prostatic hyperplasia
Patients with a total score on the AUA Symptom Index for BPH of at least 13 points at each of the three initial visits (Visits 1, 2 and 3)
A baseline prostate specific antigen (PSA) of ≤ 4.0 ng/ml
Patients who are able to give written informed consent before performing screening examinations or tests
Patients being judged by the investigator to be reliable and able to follow protocol procedures (including the return visits schedule), and cooperate in the completion of tests related to safety and efficacy

Exclusion criteria

Patients with a history of an allergy to alpha blockers, alpha/beta blockers or patients who have had a "first dose hypotensive episode" upon starting therapy with an alpha blocker
Patients who are currently being treated or who, in the last 3 months, have been treated with finasteride
Participated in an investigational drug study within 4 weeks prior to starting placebo phase
Patients taking medication in the following classes and unable to discontinue them at least two weeks before the study and for the duration of the study
- Alpha adrenergic blocking agents
- Alpha adrenergic agonists
- Drugs with anticholinergic activity (including antihistamines)
- Antispasmodics
- Parasympathomimetics and cholinomimetics
Peripheral or central neurologic disease including, but not limited to, transient ischemic attacks, stroke, dementia, multiple sclerosis, spinal cord injury, recurrent episodes of dizziness, vertigo, or loss of consciousness, clinically evident diabetic neuropathy, brain and/or spinal cord tumors
History of a pathological fall (unintentional change in body position) occurring under circumstances in which normal homeostatic mechanisms would ordinarily maintain stability, or syncope during the last year
More than one episode of angina within the past 6 months
Ambulation requiring assistance (i.e., canes, walkers, etc.)
Documented myocardial infarction (by ECG) within the past 6 months or evidence of a myocardial infarction on ECG whose age cannot be determined
New York Heart Association Class III or IV congestive heart failure
Prosthetic heart valves, cardiac devices or prior history of endocarditis
Clinically significant cardiac arrhythmias either diagnosed by ECG or recorded in the medical history, whether or not accompanied by symptoms (e.g., dizziness, presyncope, syncope, unsteadiness)
Infravesical obstruction by history due to:
- Vesical neck contracture
- Clinical suspicion of prostate carcinoma
- Mullerian duct cysts
- Urethral obstruction due to stricture, valves, sclerosis or urethral tumor
- Inflammatory or infectious conditions
- Detrusor-sphincter dyssynergia
Prior transurethral resection of the prostate (TURP) or open prostatectomy
History of instrumentation of the urinary tract (cytoscopy or catheterization) within 30 days prior to the start of the study
Prior pelvic surgery for malignancy or bowel resection
History or diagnosis of genitourinary malignancy
History of an episode of acute urinary retention within three months prior to the start of the study. (Urinary retention is to be considered acute if the patient has to be sent to a hospital for catheterization)
Patients with the current diagnosis of either bladder, ureter, or kidney stones
Patients with a current diagnosis of suspected prostatitis
Patients with a history of a neurogenic bladder
Urinary tract infection (i.e., positive urine culture) yielding pathogenic bacteria > 10**5 colony forming units (CFU) per milliliter in a properly obtained clean voided urine specimen which has been properly cultured or a laboratory report of a urinary tract infection or signs/symptoms indicative of a urinary tract infection such as [increased WBC's in the urine (15-30 white blood cells (WBC)/high powered field), dysuria, costovertebral tenderness, and urinary frequency accompanied by fever] within four weeks of baseline (Visit 3)
Evidence of significant renal dysfunction based upon a serum creatinine greater than two times the upper limit of normal levels established by the central laboratory used in this study
Laboratory tests during the screening phase:
- Hemoglobin: < 12.0 g/dL
- Leukocytes: < 3000/mm3
- Liver Enzymes: (serum glutamic oxaloacetic transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), and alkaline phosphatase): more than two times the upper limit of normal levels established by the central laboratory used in the study
Clinically relevant conditions which might interfere with the patient's ability to participate in the study including, but not limited to, the following: neurologic, gastrointestinal, cardiovascular including uncontrolled hypertension defined as a sitting diastolic blood pressure ≥ 95 mmHg with or without treatment, hepatic, renal, psychiatric, hematologic or respiratory disease, clinically relevant laboratory abnormalities based upon the investigator's judgment
Hypertensive patients initially using HYTRIN® as a monotherapy for both hypertension and BPH
Patients with cancer or diagnosis of cancer within five years of baseline
Patients who have been receiving cimetidine, warfarin, or herbal medications specifically for treatment of any urological problems within four weeks prior to the baseline
Patients who show poor compliance in the initial placebo period by:
- not returning unused medication bottles for Visits 2 or 3
- having taken < 80% or > 120% of prescribed doses during any visit interval between Visit (1, 2 or 3)
Postural symptoms during the initial placebo period, e.g., lightheadedness (on more than three occasions), fainting, blurring or loss of vision, profound weakness, or unsteadiness, with or without a change in blood pressure and/or pulse rate
Patients with poorly controlled diabetes mellitus (urine positive for glucose (> 1+) on each of 2 urinalyses during the placebo evaluation period)