Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment
NCT ID: NCT00090103
Last Updated: 2017-02-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4844 participants
INTERVENTIONAL
2003-11-30
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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dutasteride
dutasteride 0.5mg once daily
dutasteride 0.5mg once daily for 4 years
combination or single agent
Combo
Combination of dutasteride (0.5mg) and tamsulosin (0.4mg), once daily
dutasteride 0.5mg once daily for 4 years
combination or single agent
tamsulosin 0.4mg once daily for 4 years
combination agent or single agent
tamsulosin
tamsulosin 0.4mg once daily
tamsulosin 0.4mg once daily for 4 years
combination agent or single agent
Interventions
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dutasteride 0.5mg once daily for 4 years
combination or single agent
tamsulosin 0.4mg once daily for 4 years
combination agent or single agent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* males, aged ≥50 years
* clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE)
* International Prostate Symptom Score (IPSS) ≥12 points at Screening
* prostate volume ≥30 cc by transrectal ultrasonography; (TRUS)
* total serum Prostate Specific Antigen (PSA) ≥1.5ng/mL at Screening
* maximum flow rate (Qmax) \>5 mL/sec and ≤15 mL/sec and minimum voided volume of ≥125 mL at Screening (based on two voids)
* willing and able to give written informed consent and comply with study procedures
* fluent and literate in local language with the ability to read, comprehend and record information on the IPSS, BII and Patient Perception of Study Medication
* able to swallow and retain oral medication
* willing and able to participate in the study for the full 4 years.
Exclusion Criteria
* total serum PSA \>10.0ng/mL at Screening
* history or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study.
Note: If total serum PSA is \>4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, e.g. further DRE, review TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with routine clinical practice.
* previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive procedures to treat BPH.
* history of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to the Screening Visit. Routine catheterisation is acceptable with no time restriction.
* history of AUR within 3 months prior to Screening Visit.
* post-void residual volume \>250mL (suprapubic ultrasound) at Screening.
* any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections).
* history of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy.
* use of any 5-alpha-reductase inhibitor (e.g. Proscar®, Propecia®, Avodart®), any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, progestational agents), or other drugs which affect prostate volume, within past 6 months of the Screening Visit and throughout the study (other than as study medication).
* concurrent use of anabolic steroids
* use of phytotherapy for BPH within 2 weeks of Screening Visit and/or predicted to need phytotherapy during the study.
* use of any alpha-adrenoreceptor blockers (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 2 weeks of Screening Visit and/or predicted to need any alpha blockers other than tamsulosin during the study.
Note: the purpose of this criteria is to be able to standardise baseline symptom severity for all enrolled patients prior to randomisation and not to specifically exclude current alpha-adrenoreceptor blocker users from participation in the study.
* use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephrine, ephedrine) or anticholinergics (e.g. oxybutynin, propantheline) or cholinergics (e.g. bethanecol chloride) within 48 hours prior to all uroflowmetry assessments.
* hypersensitivity to any alpha-/beta- adrenoreceptor blocker or 5-alpha-reductase inhibitor, or other chemically-related drugs.
* concurrent use of drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin.
* history of hepatic impairment or abnormal liver function tests at Screening defined as alanine aminotransferase (ALT), aspartate aminotranferase (AST), and/or alkaline phosphatase \>2 times the upper limit of normal, or total bilirubin \>1.5 times the upper limit of normal (unless associated with predominantly indirect bilirubin elevation or Gilbert's syndrome).
* history of renal insufficiency, or serum creatinine \>1.5 times the upper limit of normal or serum creatinine ≥1.5 mg/dL at Screening.
* prior history of malignancies other than basal cell carcinoma or squamous cell carcinoma of the skin within the past 5 years. Subjects with a prior malignancy who have had no evidence of disease for at least the past 5 years are eligible.
* history of any illness that in the opinion of the investigator might confound the results of the study or poses additional risk to the patient.
* any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
* history of postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury.
* history of unsuccessful treatment with tamsulosin or 'first dose' hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy.
* history of unsuccessful treatment with finasteride or dutasteride
* history or current evidence of drug or alcohol abuse within the previous 12 months.
* participation in any investigational or marketed drug trial within 30 days (or 5 half-lives whichever is the longer) preceding the Screening Visit and/or during the course of this study.
50 Years
MALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Calhoun, Georgia, United States
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Decatur, Georgia, United States
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Marietta, Georgia, United States
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Meridian, Idaho, United States
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Wheaton, Illinois, United States
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Winfield, Illinois, United States
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Belleville, Illinois, United States
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Peoria, Illinois, United States
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Peoria, Illinois, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Columbiana, Alabama, United States
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Hoover, Alabama, United States
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Anchorage, Alaska, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, Arizona, United States
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Beverly Hills, California, United States
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Concord, California, United States
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Glendora, California, United States
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Greenbrae, California, United States
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Irvine, California, United States
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La Jolla, California, United States
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Laguna Woods, California, United States
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Los Angelas, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Modesto, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Vista, California, United States
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Aventura, Florida, United States
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Bay Pines, Florida, United States
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Coral Gables, Florida, United States
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Daytona Beach, Florida, United States
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Lake Worth, Florida, United States
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Miami, Florida, United States
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New Smyrna Beach, Florida, United States
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Ocala, Florida, United States
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Orange City, Florida, United States
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Pensacola, Florida, United States
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Pinecrest, Florida, United States
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Saint Augustine, Florida, United States
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Spring Hill, Florida, United States
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St. Petersburg, Florida, United States
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St. Petersburg, Florida, United States
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Stuart, Florida, United States
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Tallahassee, Florida, United States
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Wellington, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Blue Ridge, Georgia, United States
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Evansville, Indiana, United States
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Jeffersonville, Indiana, United States
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Newburgh, Indiana, United States
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South Bend, Indiana, United States
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Des Moines, Iowa, United States
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Wichita, Kansas, United States
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Murray, Kentucky, United States
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Bossier City, Louisiana, United States
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Laurel, Maryland, United States
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Minneapolis, Minnesota, United States
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Picayune, Mississippi, United States
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Kansas City, Missouri, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Hillsborough, New Jersey, United States
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Perth Amboy, New Jersey, United States
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Somerville, New Jersey, United States
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Albuquerque, New Mexico, United States
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Bay Shore, New York, United States
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Garden City, New York, United States
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Great Neck, New York, United States
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Lewiston, New York, United States
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Asheboro, North Carolina, United States
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Cary, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Fayetteville, North Carolina, United States
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Greensboro, North Carolina, United States
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Salisbury, North Carolina, United States
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Bismarck, North Dakota, United States
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Bellbrook, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Fleetwood, Pennsylvania, United States
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Providence, Rhode Island, United States
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Nashville, Tennessee, United States
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Athes, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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New Brunfels, Texas, United States
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San Antonio, Texas, United States
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Temple, Texas, United States
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Texarkana, Texas, United States
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Salt Lake City, Utah, United States
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Alexandria, Virginia, United States
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Bellevue, Washington, United States
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Mountlake Terrace, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Antwerp, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Genk, , Belgium
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La Louvière, , Belgium
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Liège, , Belgium
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Roeselare, , Belgium
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Belo Horizonte, Minas Gerais, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Surrey, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Saint John, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Kentville, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Brantford, Ontario, Canada
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Courtice, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Guelph, Ontario, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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London, Ontario, Canada
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North Bay, Ontario, Canada
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Oakville, Ontario, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Hradec Králové, , Czechia
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Ostrava - Poruba, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Roudnice nad Labem, , Czechia
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Aalborg, , Denmark
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Aarhus N, , Denmark
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Fredericia, , Denmark
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Randers, , Denmark
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Tartu, , Estonia
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Helsinki, , Finland
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Jakobstad, , Finland
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Kouvola, , Finland
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Kuopio, , Finland
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Tampere, , Finland
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Bully-les-Mines, Hauts-de-France, France
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Agny, , France
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Angers, , France
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Annecy, , France
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Arras, , France
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Athis-Mons, , France
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Besançon, , France
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Bouchemaine, , France
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Broglie, , France
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Castelneau Le Nez, , France
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Chambéry, , France
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Chilly-Mazarin, , France
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Cournonterral, , France
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Créteil, , France
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Domarin, , France
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Épinay-sur-Orge, , France
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Évreux, , France
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Évreux, , France
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Gif-sur-Yvette, , France
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Grenoble, , France
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La Seyne-sur-Mer, , France
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Lamarque, , France
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Laval, , France
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Le Brusc, , France
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Le Kremlin-Bicêtre, , France
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Les Mureaux, , France
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Lesparre-Médoc, , France
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Linas, , France
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Longpont-sur-Orge, , France
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Lyon, , France
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Melun, , France
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Meudon, , France
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Meylan, , France
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Mont-de-Marsan, , France
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Montauban, , France
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Montpelier, , France
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Montpellier, , France
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Montpellier, , France
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Orléans, , France
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Paris, , France
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Pontonx Sur Adour, , France
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Roanne, , France
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Saint-Chamond, , France
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Saint-Denis, , France
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Saint-Egrève, , France
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Saint-Galmier, , France
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Saint-Georges-dOrques, , France
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Saint-Germain-Lespinasse, , France
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Saint-Sébastien-de-Morsent, , France
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Sainte-Suzanne, , France
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Sanary-sur-Mer, , France
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Sarlat-la-Canéda, , France
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Seysses, , France
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Six-Fours-les-Plages, , France
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Suresnes, , France
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Toulon, , France
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Tours, , France
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Vaucresson, , France
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Verneuil-sur-Seine, , France
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Villejuif, , France
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Villeneuve-lès-Maguelone, , France
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Vourey, , France
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Aalen, Baden-Wurttemberg, Germany
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Konstanz, Baden-Wurttemberg, Germany
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Mosbach, Baden-Wurttemberg, Germany
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Rottweil, Baden-Wurttemberg, Germany
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Stockach, Baden-Wurttemberg, Germany
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Aichach, Bavaria, Germany
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Amberg, Bavaria, Germany
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Augsburg, Bavaria, Germany
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Graefeling, Bavaria, Germany
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Neu-Ulm, Bavaria, Germany
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Schongau, Bavaria, Germany
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Wertingen, Bavaria, Germany
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Hagenow, Brandenburg, Germany
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Lauchhammer, Brandenburg, Germany
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Oranienburg, Brandenburg, Germany
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Senftenberg, Brandenburg, Germany
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Hamburg, City state of Hamburg, Germany
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Hamburg, City state of Hamburg, Germany
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Alzenau, Hesse, Germany
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Frankfurt am Main, Hesse, Germany
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Fulda, Hesse, Germany
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Giessen, Hesse, Germany
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Kassel, Hesse, Germany
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Koenigstein, Hesse, Germany
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Marburg, Hesse, Germany
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Schwalbach, Hesse, Germany
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Delmenhorst, Lower Saxony, Germany
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Holzminden, Lower Saxony, Germany
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Oldenburg, Lower Saxony, Germany
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Osnabrück, Lower Saxony, Germany
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Grimmen, Mecklenburg-Vorpommern, Germany
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Parchim, Mecklenburg-Vorpommern, Germany
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Dülmen, North Rhine-Westphalia, Germany
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Stadtlohn, North Rhine-Westphalia, Germany
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Koblenz, Rhineland-Palatinate, Germany
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Hohenstein-Ernsttal, Saxony, Germany
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Leipzig, Saxony, Germany
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Leipzig, Saxony, Germany
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Leipzig, Saxony, Germany
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Halle, Saxony-Anhalt, Germany
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Hettstedt, Saxony-Anhalt, Germany
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Merseburg, Saxony-Anhalt, Germany
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Husum, Schleswig-Holstein, Germany
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Kiel, Schleswig-Holstein, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Apolda, Thuringia, Germany
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Pátrai, , Greece
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Polygyros, , Greece
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Thassaloniki, , Greece
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Budapest, , Hungary
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Sopron, , Hungary
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Székesfehérvár, , Hungary
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Veszprém, , Hungary
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Reykjavik, , Iceland
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Haifa, , Israel
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Haifa, , Israel
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Holon, , Israel
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Kfar Saba, , Israel
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Ramat Gan, , Israel
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Zrifin, , Israel
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Catanzaro, Calabria, Italy
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Avellino, Campania, Italy
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Castellamare Di Stabia (NA), Campania, Italy
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Napoli, Campania, Italy
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San Felice A Cancello Caserta, Campania, Italy
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Torre Del Greco (NA), Campania, Italy
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Modena, Emilia-Romagna, Italy
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Udine, Friuli Venezia Giulia, Italy
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Rome, Lazio, Italy
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Genoa, Liguria, Italy
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Lecco, Lombardy, Italy
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Milan, Lombardy, Italy
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Ivrea (TO), Piedmont, Italy
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Novara, Piedmont, Italy
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Turin, Piedmont, Italy
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Cagliari, Sardinia, Italy
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Acireale (CT), Sicily, Italy
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Bagno A Ripoli (FI), Tuscany, Italy
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Florence, Tuscany, Italy
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Siena, Tuscany, Italy
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Portogruaro (VE), Veneto, Italy
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Kaunas, , Lithuania
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Klaipėda, , Lithuania
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Vilnius, , Lithuania
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Guadalajara, Jalisco, Mexico
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Zapopan, Jalisco, Mexico
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Zapopan, Jalisco, Jalisco, Mexico
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Mexico City, , Mexico
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Mexico City, , Mexico
GSK Investigational Site
México, , Mexico
GSK Investigational Site
Alkmaar, , Netherlands
GSK Investigational Site
Amstelveen, , Netherlands
GSK Investigational Site
Amsterdam, , Netherlands
GSK Investigational Site
Amsterdam, , Netherlands
GSK Investigational Site
Arnhem, , Netherlands
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Doetinchem, , Netherlands
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Enschede, , Netherlands
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Etten-Leur, , Netherlands
GSK Investigational Site
Groningen, , Netherlands
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Groningen, , Netherlands
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Heerlen, , Netherlands
GSK Investigational Site
Hilversum, , Netherlands
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Hoofddorp, , Netherlands
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Maastricht, , Netherlands
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The Hague, , Netherlands
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Tilburg, , Netherlands
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Tilburg, , Netherlands
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Veldhoven, , Netherlands
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Winterswijk, , Netherlands
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Zwijndrecht, , Netherlands
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Ålesund, , Norway
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Bergen, , Norway
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Bodø, , Norway
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Haugesund, , Norway
GSK Investigational Site
Moelv, , Norway
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Nøtterøy, , Norway
GSK Investigational Site
Oslo, , Norway
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Oslo, , Norway
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Porsgrunn, , Norway
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Tønsberg, , Norway
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Manila, , Philippines
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Quezon City, , Philippines
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Gdansk, , Poland
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Krakow, , Poland
GSK Investigational Site
Krakow, , Poland
GSK Investigational Site
Lublin, , Poland
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Wroclaw, , Poland
GSK Investigational Site
Abrantes, , Portugal
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Lisbon, , Portugal
GSK Investigational Site
Lisbon, , Portugal
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Porto, , Portugal
GSK Investigational Site
Porto, , Portugal
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S. Martinho Do Bispo, , Portugal
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Ponce, Puerto Rico, Puerto Rico
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Santurce, Puerto Rico, Puerto Rico
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Arad, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Iași, , Romania
GSK Investigational Site
Timișoara, , Romania
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Moscow, , Russia
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Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Smolensk, , Russia
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
GSK Investigational Site
Martin, , Slovakia
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Skalica, , Slovakia
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Žilina, , Slovakia
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Cape Town, , South Africa
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Claremont, , South Africa
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Somerset West, , South Africa
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Sunninghill, , South Africa
GSK Investigational Site
Pusan, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
A Coruña, , Spain
GSK Investigational Site
Alava, , Spain
GSK Investigational Site
Alcázar de San Juan (Ciudad Real), , Spain
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Badajoz, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Burgos, , Spain
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Ciudad Real, , Spain
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Donostia / San Sebastian, , Spain
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Elche (Alicante), , Spain
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Gijón, , Spain
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Guadalajara, , Spain
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Jerez de la Frontera, , Spain
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Langreo (Oviedo), , Spain
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Las Palmas, , Spain
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Las Palmas de Gran Canaria, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Manacor (Palma de Mallorca), , Spain
GSK Investigational Site
Marbella, , Spain
GSK Investigational Site
Málaga, , Spain
GSK Investigational Site
Mendaro, Guipuzcoa, , Spain
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Mérida, , Spain
GSK Investigational Site
Murcia, , Spain
GSK Investigational Site
Palma de Mallorca, , Spain
GSK Investigational Site
Pamplona, , Spain
GSK Investigational Site
Pontevedra, , Spain
GSK Investigational Site
Sabadell (Barcelona), , Spain
GSK Investigational Site
San Sebastián, , Spain
GSK Investigational Site
Santa Cruz de Tenerife, , Spain
GSK Investigational Site
Santander, , Spain
GSK Investigational Site
Santander, , Spain
GSK Investigational Site
Santiago de Compostela, , Spain
GSK Investigational Site
Tortosa, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Vigo (Pontevedra), , Spain
GSK Investigational Site
Vigo/Pontevedra, , Spain
GSK Investigational Site
Vitoria-Gasteiz, , Spain
GSK Investigational Site
Vizcaya, , Spain
GSK Investigational Site
Kaohsiung City, , Taiwan
GSK Investigational Site
Taichung, , Taiwan
GSK Investigational Site
Tainan City, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taoyuan District, , Taiwan
GSK Investigational Site
Bangkok, , Thailand
GSK Investigational Site
Bangkok, , Thailand
GSK Investigational Site
Bangkok, , Thailand
GSK Investigational Site
Chiang Mai, , Thailand
GSK Investigational Site
Sousse, , Tunisia
GSK Investigational Site
Tunis, , Tunisia
GSK Investigational Site
Tunis, , Tunisia
GSK Investigational Site
Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Sıhhiye/Ankara, , Turkey (Türkiye)
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Swansea, Glamorgan, United Kingdom
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Buckshaw Village, Chorley, Lancashire, United Kingdom
GSK Investigational Site
Northwood, Middlesex, United Kingdom
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom
GSK Investigational Site
Chichester, Sussex West, United Kingdom
GSK Investigational Site
Clydebank, Glasgow, , United Kingdom
GSK Investigational Site
Dundee, , United Kingdom
GSK Investigational Site
Edgbaston, Birmingham, , United Kingdom
GSK Investigational Site
Manchester, , United Kingdom
GSK Investigational Site
Waterloo, Liverpool, , United Kingdom
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, ,
Countries
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References
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Antonanzas F, Brenes F, Molero JM, Fernandez-Pro A, Huerta A, Palencia R, Cozar JM. [Cost-effectiveness of the combination therapy of dutasteride and tamsulosin in the treatment of benign prostatic hyperlasia in Spain]. Actas Urol Esp. 2011 Feb;35(2):65-71. doi: 10.1016/j.acuro.2010.11.008. Epub 2011 Jan 26. Spanish.
Barkin J, Roehrborn CG, Siami P, Haillot O, Morrill B, Black L, Montorsi F; CombAT Study Group. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 2-year data from the CombAT trial. BJU Int. 2009 Apr;103(7):919-26. doi: 10.1111/j.1464-410X.2009.08196.x. Epub 2009 Feb 23.
Bjerklund Johansen TE, Baker TM, Black LK. Cost-effectiveness of combination therapy for treatment of benign prostatic hyperplasia: a model based on the findings of the Combination of Avodart and Tamsulosin trial. BJU Int. 2012 Mar;109(5):731-8. doi: 10.1111/j.1464-410X.2011.10511.x. Epub 2011 Sep 20.
Black L, Grove A, Morrill B. The psychometric validation of a US English satisfaction measure for patients with benign prostatic hyperplasia and lower urinary tract symptoms. Health Qual Life Outcomes. 2009 Jun 19;7:55. doi: 10.1186/1477-7525-7-55.
Chung BH, Roehrborn CG, Siami P, Major-Walker K, Morrill BB, Wilson TH, Montorsi F. Efficacy and safety of dutasteride, tamsulosin and their combination in a subpopulation of the CombAT study: 2-year results in Asian men with moderate-to-severe BPH. Prostate Cancer Prostatic Dis. 2009;12(2):152-9. doi: 10.1038/pcan.2008.49. Epub 2008 Sep 23.
Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Nandy I, Morrill BB, Gagnier RP, Montorsi F; CombAT Study Group. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol. 2010 Jan;57(1):123-31. doi: 10.1016/j.eururo.2009.09.035. Epub 2009 Sep 19.
Roehrborn CG, Andriole GL, Wilson TH, Castro R, Rittmaster RS. Effect of dutasteride on prostate biopsy rates and the diagnosis of prostate cancer in men with lower urinary tract symptoms and enlarged prostates in the Combination of Avodart and Tamsulosin trial. Eur Urol. 2011 Feb;59(2):244-9. doi: 10.1016/j.eururo.2010.10.040. Epub 2010 Nov 4.
Roehrborn CG, Barkin J, Siami P, Tubaro A, Wilson TH, Morrill BB, Gagnier RP. Clinical outcomes after combined therapy with dutasteride plus tamsulosin or either monotherapy in men with benign prostatic hyperplasia (BPH) by baseline characteristics: 4-year results from the randomized, double-blind Combination of Avodart and Tamsulosin (CombAT) trial. BJU Int. 2011 Mar;107(6):946-54. doi: 10.1111/j.1464-410X.2011.10124.x. Epub 2011 Feb 18.
Roehrborn CG, Wilson TH, Black LK. Quantifying the contribution of symptom improvement to satisfaction of men with moderate to severe benign prostatic hyperplasia: 4-year data from the CombAT trial. J Urol. 2012 May;187(5):1732-8. doi: 10.1016/j.juro.2011.12.083. Epub 2012 Mar 15.
Becher E, Roehrborn CG, Siami P, Gagnier RP, Wilson TH, Montorsi F. The effects of dutasteride, tamsulosin, and the combination on storage and voiding in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the Combination of Avodart and Tamsulosin study. Prostate Cancer Prostatic Dis. 2009;12(4):369-74. doi: 10.1038/pcan.2009.37. Epub 2009 Sep 1.
Montorsi F, Roehrborn C, Garcia-Penit J, Borre M, Roeleveld TA, Alimi JC, Gagnier P, Wilson TH. The effects of dutasteride or tamsulosin alone and in combination on storage and voiding symptoms in men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH): 4-year data from the Combination of Avodart and Tamsulosin (CombAT) study. BJU Int. 2011 May;107(9):1426-31. doi: 10.1111/j.1464-410X.2011.10129.x. Epub 2011 Feb 23.
Montorsi F, Henkel T, Geboers A, Mirone V, Arrosagaray P, Morrill B, Black L. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study. Int J Clin Pract. 2010 Jul;64(8):1042-51. doi: 10.1111/j.1742-1241.2010.02428.x. Epub 2010 May 7.
Haillot O, Fraga A, Maciukiewicz P, Pushkar D, Tammela T, Hofner K, Chantada V, Gagnier P, Morrill B. The effects of combination therapy with dutasteride plus tamsulosin on clinical outcomes in men with symptomatic BPH: 4-year post hoc analysis of European men in the CombAT study. Prostate Cancer Prostatic Dis. 2011 Dec;14(4):302-6. doi: 10.1038/pcan.2011.13. Epub 2011 Apr 19.
Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Morrill B, Montorsi F; CombAT Study Group. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol. 2008 Feb;179(2):616-21; discussion 621. doi: 10.1016/j.juro.2007.09.084. Epub 2007 Dec 21.
Study Documents
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Document Type: Annotated Case Report Form
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View DocumentDocument Type: Informed Consent Form
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View DocumentDocument Type: Statistical Analysis Plan
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View DocumentDocument Type: Clinical Study Report
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View DocumentDocument Type: Study Protocol
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View DocumentDocument Type: Individual Participant Data Set
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View DocumentDocument Type: Dataset Specification
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Other Identifiers
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ARI40005
Identifier Type: -
Identifier Source: org_study_id
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