Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)

NCT ID: NCT01534351

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-01
• Study Completion Date: 2013-11-18

Brief Summary

This study is designed to compare safety and efficacy of monotherapy finasteride to combination therapy (finasteride and tamsulosin) in Asian men with benign prostatic hyperplasia (BPH) who are at least 50 years of age or older. The primary hypotheses are that concomitantly-dosed finasteride 5 mg and tamsulosin 0.2 mg will be superior with respect to BPH symptoms compared to monotherapy with finasteride 5 mg as measured by change from baseline on the International Prostate Symptoms Score (IPSS) and will be superior with respect to prostate volume reduction compared to montherapy with tamsulosin 0.2 mg as measured by percent change from baseline in prostate volume.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Finasteride

Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.

Group Type: EXPERIMENTAL

Finasteride

Intervention Type: DRUG

Finasteride 5 mg oral tablet taken once daily.

Tamsulosin-matching placebo

Intervention Type: DRUG

Matching placebo to tamsulosin 0.2 mg oral capsule taken once daily.

Tamsulosin

Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.

Group Type: ACTIVE_COMPARATOR

Tamsulosin

Intervention Type: DRUG

Tamsulosin 0.2 mg oral capsule taken once daily.

Finasteride-matching placebo

Intervention Type: DRUG

Matching placebo to finasteride 5 mg oral tablet taken once daily.

Finasteride and Tamsulosin

Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.

Group Type: EXPERIMENTAL

Finasteride

Intervention Type: DRUG

Finasteride 5 mg oral tablet taken once daily.

Tamsulosin

Intervention Type: DRUG

Tamsulosin 0.2 mg oral capsule taken once daily.

Interventions

Finasteride

Finasteride 5 mg oral tablet taken once daily.

Intervention Type: DRUG

Tamsulosin

Tamsulosin 0.2 mg oral capsule taken once daily.

Intervention Type: DRUG

Finasteride-matching placebo

Matching placebo to finasteride 5 mg oral tablet taken once daily.

Intervention Type: DRUG

Tamsulosin-matching placebo

Matching placebo to tamsulosin 0.2 mg oral capsule taken once daily.

Intervention Type: DRUG

Other Intervention Names

Proscar®; Flomax®

Eligibility Criteria

Inclusion Criteria

• Possess a clinical diagnosis of BPH.
• Able to read, understand, and complete the study questionnaire.

Exclusion Criteria

• History or recurrent evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with participation for the full duration of the study.
• History of malignancy ≤ 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer, including prostate cancer of any duration, evidence or suspicion of prostate cancer on a previous biopsy.
• History of prostatic surgery or other invasive procedures to treat BPH or history of bladder neck obstruction, bladder cancer, and/or pelvic irradiation, urinary incontinence, recurrent urinary tract infection, urethral stricture, or bacterial prostatitis.
• History of acute urinary retention (ie, inability to fully empty bladder).
• Had invasive urinary bladder procedures (ie, cystoscopy) within 7 days prior to screening.
• Had phytotherapy within 2 weeks of screening and may need phytotherapy during the study.
• History of low blood pressure (orthostatic hypotension, hypotension [supine blood pressure less than 90/70 mm Hg]), unstable angina, or a cardiovascular or cerebral vascular event (ie, transient ischemic attack [TIA], stroke) within the previous 3 months prior to enrollment, OR a history of dizziness, vertigo or any other typical signs and symptoms of low blood pressure.
• Recent history (ie, within the past year) or active addiction, abuse, misuse of and/or dependence on drugs and/or alcohol.
• Use of herbal therapies that may impact the study (eg, Saw Palmetto) within 2 weeks of screening and/or is predicted to need herbal therapies during the study. Individuals currently taking herbal therapies may be eligible for study if willing to complete a 2-week washout period.
• Use of finasteride or a drug with a similar action during the 12 months prior to study screening. Individuals treated for short periods with 5-alpha reductase inhibitors (5ARIs) or drugs with antiandrogenic properties within 12 months of screening may be eligible for study.
• Use of a non-approved (investigational) drug within the last 4 weeks prior to enrollment, or current participation in another clinical study.
• Allergic or intolerant to finasteride and/or tamsulosin.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

0906A-149

Identifier Type: -

Identifier Source: org_study_id