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

NCT02244255 | Completed Phase 4

• 1 other identifier: 527.17
• Study Type: interventional
• Target: 1,993
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.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)
2. 2.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

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Changes in American Urological Association (AUA) symptom score index

  Pre-dose, up to day 57 after start of treatment

Secondary Outcomes (7)

• Changes in AUA bother score index

  Pre-dose, up to 57days after start of treatment

• Changes in BPH impact index score

  Pre-dose, up to 57 days after start of treatment

• Global assessment by investigator on a 5-point scale

  Day 5, up to day 57 after start of treatment

• Number of patients with clinically relevant changes from baselinein laboratory values

  Pre-dose, day 57 after start of treatment

• Number of patients with clinically significant changes in vital signs

  Pre-dose, up to 57 days after start of treatment

Study Arms (2)

FLOMAX®

EXPERIMENTAL

Drug: FLOMAX® capsules

HYTRIN®

ACTIVE COMPARATOR

Drug: Ascending doses of HYTRIN® capsules

Interventions

FLOMAX® capsules DRUG

Also known as: Tamsulosin hydrochloride

FLOMAX®

Ascending doses of HYTRIN® capsules DRUG

HYTRIN®

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 19, 2014
• Study Start: August 1, 1998
• Primary Completion: June 1, 2000
• Last Updated: September 19, 2014

Record last verified: 2014-09