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

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01534351
• Collaborator: (none)
• Enrollment: 1
• Arms: 3
• Actual Duration (Months): 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Drug: Finasteride; Drug: Tamsulosin; Drug: Finasteride-matching placebo; Drug: Tamsulosin-matching placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Nov 18, 2013
• Actual Study Completion Date: Nov 18, 2013

Arms and Interventions

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®

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in International Prostate Symptom Score (IPSS) [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.

2. Percent Change From Baseline in Prostate Volume [Baseline and Month 12]

   Prostate volume was assessed by trans-rectal ultrasound (TRUS).

3. Number of Participants Who Experienced an Adverse Event [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.

4. Number of Participants Who Discontinued Treatment Due to an Adverse Event [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

• Study Director: Medical Director, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT01534351
• Other Study ID Numbers: 0906A-149
• First Posted: Feb 16, 2012
• Last Update Posted: Aug 29, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Tamsulosin; Finasteride

Study Results

Participant Flow

Pre-assignment Detail	Prior to early study discontinuation, 3 sites were initiated and screened a total of 8 participants. Of the 8 participants, one participant was randomized to finasteride 5 mg once daily for 39 days.

Arm/Group Title	Finasteride	Tamsulosin	Finasteride and Tamsulosin
Arm/Group Description	Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg 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 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg 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 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.
Period Title: Overall Study
STARTED	1	0	0
COMPLETED	0	0	0
NOT COMPLETED	1	0	0

Baseline Characteristics

Arm/Group Title	Finasteride	Tamsulosin	Finasteride and Tamsulosin	Total
Arm/Group Description	Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg 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 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg 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 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.	Total of all reporting groups
Overall Participants	1	0	0	1
Age (Count of Participants)
<=18 years	0 0%	0 NaN
Between 18 and 65 years	1 100%	1 Infinity
>=65 years	0 0%	0 NaN
Sex: Female, Male (Count of Participants)
Female	0 0%	0 NaN
Male	1 100%	1 Infinity

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in International Prostate Symptom Score (IPSS)
Description	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.
Time Frame	Baseline and Month 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Finasteride	Tamsulosin	Finasteride and Tamsulosin
Arm/Group Description	Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg 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 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg 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 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.
Measure Participants	0	0	0

2. Primary Outcome

Title	Percent Change From Baseline in Prostate Volume
Description	Prostate volume was assessed by trans-rectal ultrasound (TRUS).
Time Frame	Baseline and Month 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Finasteride	Tamsulosin	Finasteride and Tamsulosin
Arm/Group Description	Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg 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 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg 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 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.
Measure Participants	0	0	0

3. Primary Outcome

Title	Number of Participants Who Experienced an Adverse Event
Description	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.
Time Frame	Up to 54 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Finasteride	Tamsulosin	Finasteride and Tamsulosin
Arm/Group Description	Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg 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 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg 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 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.
Measure Participants	1	0	0
Number [Participants]	0 0%

4. Primary Outcome

Title	Number of Participants Who Discontinued Treatment Due to an Adverse Event
Description	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.
Time Frame	Up to 52 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Finasteride	Tamsulosin	Finasteride and Tamsulosin
Arm/Group Description	Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg 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 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg 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 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.
Measure Participants	1	0	0
Number [Participants]	0 0%

Adverse Events

Time Frame	Up to 54 weeks
Arm/Group Title	Finasteride		Tamsulosin		Finasteride and Tamsulosin
Arm/Group Description	Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg 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 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg 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 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.
All Cause Mortality
	Finasteride		Tamsulosin		Finasteride and Tamsulosin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Finasteride		Tamsulosin		Finasteride and Tamsulosin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Finasteride		Tamsulosin		Finasteride and Tamsulosin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

The trial was terminated for business reasons.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.