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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01534351
First received: February 13, 2012
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: Finasteride (MK-906)
Drug: Tamsulosin
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from Baseline in International Prostate Symptom Score (IPSS) [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Prostate Volume [ Time Frame: At Month 12 ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: August 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Finasteride and Placebo Drug: Finasteride (MK-906)
5 mg tablet for once-daily oral administration, for up to 12 months duration
Other Name: Proscar®
Other: Placebo
Tablet (Finasteride [MK-906]) or capsule (Tamsulosin) for once-daily oral administration, for up to 12 months duration
Active Comparator: Tamsulosin and Placebo Drug: Tamsulosin
0.2 mg capsule for once-daily oral administration, for up to 12 months duration
Other Name: Flomax®
Other: Placebo
Tablet (Finasteride [MK-906]) or capsule (Tamsulosin) for once-daily oral administration, for up to 12 months duration
Experimental: Finasteride and Tamsulosin Drug: Finasteride (MK-906)
5 mg tablet for once-daily oral administration, for up to 12 months duration
Other Name: Proscar®
Drug: Tamsulosin
0.2 mg capsule for once-daily oral administration, for up to 12 months duration
Other Name: Flomax®

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 urinary bladder neck obstruction, urinary bladder cancer, and/or pelvic irradiation, urinary incontinence, recurrent urinary tract infection, urethral stricture, or bacterial prostatitis.
  • History or current condition 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01534351     History of Changes
Other Study ID Numbers: 0906A-149
Study First Received: February 13, 2012
Last Updated: November 3, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Finasteride
Tamsulosin
5-alpha Reductase Inhibitors
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 20, 2014