Benign Prostatic HyperplasiaPhase 3NCT01534351

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

A Phase 3 study testing Finasteride and Tamsulosin in people with Benign Prostatic Hyperplasia, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 50 years and older, men only
Conditions the study is for: Benign Prostatic Hyperplasia
What is being tested?: Finasteride and Tamsulosin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1 participants
Where: No sites listed yet
Study dates: 1 Aug 2013to 18 Nov 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 12Show fewer

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.

About this study

Official title: 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.

Conditions: Benign Prostatic Hyperplasia
Being tested: Finasteride, Tamsulosin, Finasteride-matching placebo, Tamsulosin-matching placebo
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FinasterideDrug
Also called Proscar®
Finasteride 5 mg oral tablet taken once daily.
TamsulosinDrug
Also called Flomax®
Tamsulosin 0.2 mg oral capsule taken once daily.
Finasteride-matching placeboDrug
Matching placebo to finasteride 5 mg oral tablet taken once daily.
Tamsulosin-matching placeboDrug
Matching placebo to tamsulosin 0.2 mg oral capsule taken once daily.

Study groups in NCT01534351
Study group	Role	What they receive
Finasteride	Experimental	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. Receives: Drug: Finasteride; Drug: Tamsulosin-matching placebo
Tamsulosin	Active comparator	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. Receives: Drug: Tamsulosin; Drug: Finasteride-matching placebo
Finasteride and Tamsulosin	Experimental	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. Receives: Drug: Finasteride; Drug: Tamsulosin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Month 12
Percent Change From Baseline in Prostate Volume
Prostate volume was assessed by trans-rectal ultrasound (TRUS).
Measured: 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.
Measured: 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.
Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201318 Nov 2013

First posted16 Feb 2012 (estimated)
Study start1 Aug 2013
Primary completion18 Nov 2013
Study completion18 Nov 2013

Why it stopped: Business Reasons

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01534351
Sponsor's protocol ID: 0906A-149
Status last verified: Jul 2018
First submitted: 13 Feb 2012
Last updated: 29 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
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Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
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Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
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Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
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All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT01534351
Acronym / sponsor ID: 0906A-149
Conditions: Benign Prostatic Hyperplasia
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business Reasons
Enrolment: 1 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 1 Aug 2013 (actual)
Primary completion: 18 Nov 2013 (actual)
Study completion: 18 Nov 2013 (actual)
First posted: 16 Feb 2012 (estimated)
Results: Posted 3 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Finasteride	Experimental	Drug: Finasteride, Drug: Tamsulosin-matching placeboFinasteride 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.
Tamsulosin	Active comparator	Drug: Tamsulosin, Drug: Finasteride-matching placeboTamsulosin 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.
Finasteride and Tamsulosin	Experimental	Drug: Finasteride, Drug: TamsulosinFinasteride 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.

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FinasterideAlso: Proscar®Finasteride 5 mg oral tablet taken once daily.	Drug	Finasteride, Finasteride and Tamsulosin
TamsulosinAlso: Flomax®Tamsulosin 0.2 mg oral capsule taken once daily.	Drug	Finasteride and Tamsulosin, Tamsulosin
Finasteride-matching placeboMatching placebo to finasteride 5 mg oral tablet taken once daily.	Drug	Tamsulosin
Tamsulosin-matching placeboMatching placebo to tamsulosin 0.2 mg oral capsule taken once daily.	Drug	Finasteride

Primary outcome

Change From Baseline in International Prostate Symptom Score (IPSS)
Time frame: Baseline and Month 12
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.
Percent Change From Baseline in Prostate Volume
Time frame: Baseline and Month 12
Prostate volume was assessed by trans-rectal ultrasound (TRUS).
Number of Participants Who Experienced an Adverse Event
Time frame: Up to 54 weeks
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.
Number of Participants Who Discontinued Treatment Due to an Adverse Event
Time frame: Up to 52 weeks
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.

Results and safety

Results posted to the registry on 3 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Finasteride	1	0
Tamsulosin	0	0
Finasteride and Tamsulosin	0	0

Primary outcome: Change From Baseline in International Prostate Symptom Score (IPSS)

Time frame: Baseline and Month 12

Population analysed: Full Analysis Set (FAS) - population consists of all randomized participants who received at least one dose of study treatment, at least one post-randomization observation for the analysis endpoint, and baseline data for those analyses that require baseline data. As only one participant was randomized in the study, no analyses were performed.

Primary outcome: Percent Change From Baseline in Prostate Volume

Time frame: Baseline and Month 12

Primary outcome: Number of Participants Who Experienced an Adverse Event

Time frame: Up to 54 weeks. Number. Unit: Participants

Measure	Finasteride n = 1	Tamsulosin n = 0	Finasteride and Tamsulosin n = 0
Value	0	–	–

Primary outcome: Number of Participants Who Discontinued Treatment Due to an Adverse Event

Time frame: Up to 52 weeks. Number. Unit: Participants

Measure	Finasteride n = 1	Tamsulosin n = 0	Finasteride and Tamsulosin n = 0
Value	0	–	–

Population analysed: All Participants as Treated (APaT) - population consists of all randomized participants who received at least one dose of study treatment. As only one participant was randomized in the study, no analyses were performed.

Adverse events

Time frame: Up to 54 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Finasteride	0 of 1 (0%)	0 of 1 (0%)	Not reported
Tamsulosin	0 of 0	0 of 0	Not reported
Finasteride and Tamsulosin	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): The trial was terminated for business reasons.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Benign Prostatic Hyperplasia

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
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Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
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ProVIDE Studies Post Exit Analysis
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Finasteride and Tamsulosin in people with Benign Prostatic Hyperplasia, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in International Prostate Symptom Score (IPSS) (time frame: Baseline and Month 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01534351.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.