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

A Phase III, Randomized Clinical Trial to Study the Safety and Efficacy of MK-906 (Finasteride) and Tamsulosin Administered Either Alone or Concomitantly in Patients With Benign Prostatic Hyperplasia (BPH)

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.

Study Overview

• Status: Terminated
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Finasteride; Drug: Tamsulosin-matching placebo; Drug: Tamsulosin; Drug: Finasteride-matching placebo

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Finasteride; Finasteride 5 mg oral tablet taken once daily.; Other Names: Proscar®; Drug: Tamsulosin-matching placebo; Matching placebo to tamsulosin 0.2 mg oral capsule taken once daily.
Active Comparator: 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.	Drug: Tamsulosin; Tamsulosin 0.2 mg oral capsule taken once daily.; Other Names: Flomax®; Drug: Finasteride-matching placebo; Matching placebo to finasteride 5 mg oral tablet taken once daily.
Experimental: 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.	Drug: Finasteride; Finasteride 5 mg oral tablet taken once daily.; Other Names: Proscar®; Drug: Tamsulosin; Tamsulosin 0.2 mg oral capsule taken once daily.; Other Names: Flomax®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in International Prostate Symptom Score (IPSS)	The IPSS is a self-administered questionnaire used to measure the severity of lower urinary tract symptoms among men suspected of having symptomatic Benign Prostatic Hyperplasia (BPH). The IPSS consists of 8 questions (7 urinary symptom questions + 1 quality of life question). The 7 symptom questions inquire about frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency. Each of the 7 questions has an ordered categorical response frame scored from 0 (not at all) to 5 (almost all the time). The total score is the sum of the 7 items and therefore has a range of 0 to 35. Higher scores indicate higher symptom severity. The quality of life question is a single global question rated on a scale of 0 (delighted) to 6 (terrible) asking the participant to rate how they feel about their current urinary symptom status. The IPSS-QoL question is not used in the calculation of the total symptom score.	Baseline and Month 12
Percent Change From Baseline in Prostate Volume	Prostate volume was assessed by trans-rectal ultrasound (TRUS).	Baseline and Month 12
Number of Participants Who Experienced an Adverse Event	An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.	Up to 54 weeks
Number of Participants Who Discontinued Treatment Due to an Adverse Event	An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.	Up to 52 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): November 18, 2013
• Study Completion (Actual): November 18, 2013

Study Registration Dates

• First Submitted: February 13, 2012
• First Submitted That Met QC Criteria: February 13, 2012
• First Posted (Estimate): February 16, 2012

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; 5-alpha Reductase Inhibitors; Tamsulosin; Finasteride
• Other Study ID Numbers: 0906A-149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Study Data/Documents

1. CSR Synopsis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No