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Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients (ABSOLUTE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by Soo Woong Kim, MD, Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01736033
First Posted: November 29, 2012
Last Update Posted: May 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Astellas Pharma Korea, Inc.
Medical Research Collaborating Center, Seoul, Korea
Information provided by (Responsible Party):
Soo Woong Kim, MD, Seoul National University Hospital
November 18, 2012
November 29, 2012
May 14, 2014
February 2012
February 2017   (Final data collection date for primary outcome measure)
Clinical Progression [ Time Frame: 1 & 2 months after baseline, and then every 3 months up to 4 years ]

One of below

  • Deterioration of the symptoms
  • Acute urinary retention
  • Renal failure
  • Recurrent urinary tract infection
  • Urinary incontinence
  • Surgical procedure related to benign prostate hyperplasia
Same as current
Complete list of historical versions of study NCT01736033 on ClinicalTrials.gov Archive Site
  • International Prostate Symptom Score(IPSS) [ Time Frame: 1 & 2 months after baseline, and then every 3 months up to 4 years ]
  • International Consultation on Incontinence Modular Questionnaire(ICIQ) male LUTS-short form [ Time Frame: every 6 months up to 4 years ]
  • Uroflowmetry [ Time Frame: every 6 months up to 4 years ]
    including Qmax, voided volume and post-void residual volume(PVR)
  • Prostate volume [ Time Frame: every 1 year up to 4 years ]
  • Global Response Assessment(GRA) [ Time Frame: every 1 year up to 4 years ]
  • PSA level [ Time Frame: every 1 year up to 4 years ]
    PSA level will be examined in the central laboratory and be reported to each center as an adjusted number. It is because PSA level tends to decrease to 50% of baseline after taking finasteride for 1~4 years, so there is possibilities that the blindedness is broken with the actual result.
  • Blood Chemistry [ Time Frame: every 1 year up to 4 years ]
    including Sodium, Potassium, Glucose, Urea nitrogen, Creatinine, ASpartate Transaminase(AST), ALanine Transaminase(ALT), Total bilirubin
  • Adverse Events [ Time Frame: every visit up to 4 years ]
  • Physical examination [ Time Frame: every 1 year up to 4 years ]
    Digital Rectal Exam, Breast exam
  • Male Sexual Health Questionnaire [ Time Frame: every 6 months up to 4 years ]
Same as current
Not Provided
Not Provided
 
Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients
A Multicenter, Randomized, Double-blind, Clinical Study to Investigate the Efficacy and Safety of Treatment With Tamsulosin 0.2mg Mono and Tamsulosin 0.2mg, Finasteride 5mg Combination Therapy in Patients With LUTS/BPH
The purpose of this study is to evaluate the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in benign prostate hyperplasia patients, and suggest guidelines of the combination therapy.

Even though it should be decided on patients cautiously under careful consideration about prostate volume, Prostate Specific Antigen(PSA) level, symptom score and maximum uroflow, recently the combination therapy of alpha-blocker and 5-alpha reductase inhibitor has been tried imprudently in Korea.

As a result of several clinical trials which had conducted overseas for releasing the combination drug of alpha-blocker and 5-alpha reductase inhibitor, the superiority of the combination therapy has been proved, however, plenty of patients still don't derive additional profit from it.

Therefore, in this study, the investigators anticipate to meet with meaningful results on the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in Korean benign prostate hyperplasia patients, and provide guidelines of the combination therapy.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Benign Prostate Hyperplasia
  • Drug: Tamsulosin
    1 tablet(0.2mg) orally q.d.
    Other Names:
    • Harnal D (brand name in Asia)
    • Flomax
  • Drug: Finasteride
    1 tablet(5mg) orally q.d.
    Other Name: Proscar
  • Drug: Placebo
    1 tablet(0.2mg) orally q.d.
  • Placebo Comparator: Tamsulosin + Placebo
    Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression
    Interventions:
    • Drug: Tamsulosin
    • Drug: Placebo
  • Active Comparator: Tamsulosin + Finasteride
    Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression
    Interventions:
    • Drug: Tamsulosin
    • Drug: Finasteride

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
545
June 2017
February 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male patients aged over 50
  • Clinically diagnosed benign prostate hyperplasia(BPH)
  • 8 ≤ IPSS ≤ 30
  • 4 ml/sec ≤ Q max ≤ 15 ml/sec
  • minimum voided volume ≥ 125 ml
  • Post voided residual volume ≤ 250
  • Volunteer who singed on informed consent documents

Exclusion Criteria:

  • Past history of surgical procedure experience related to BPH
  • Past history of taking 5-alpha reductase inhibitor(5-ARI) within 6 months before screening, or for more than 12 months regardless of the point of time
  • Past history of taking alpha blocker within 2 weeks before screening
  • Past history of acute urinary retention within 3 months before screening
  • Serum PSA ≥ 10 ng/ml (but, in the case of 4 ng/ml ≤ PSA < 10 ng/ml, the patients can be included only if prostate cancer is excluded by prostate biopsy)
  • Anatomical abnormalities of lower urinary tracts(urethrostenosis, diverticulosis, bladder neck contracture)
  • Clinical status that affects voiding other than BPH(neurogenic bladder, Chronic Prostatitis/Chronic Pelvic Pain Syndrome, urinary infection, etc.)
  • Unstable and significant medical condition including below

    • Unstable angina pectoris, myocardial infarction, cerebrovascular disease within 6 months before screening
    • Past history of malignant tumor including skin basal cell carcinoma within 5 years before screening
    • Medically uncontrollable diabetes mellitus, peptic ulcer disease
    • Severe hepatic diseases
    • Past history of renal failure or renal disease (serum creatinine > 1.4mg/dl)
    • Condition expected serious adverse event due to the investigational drug
  • Other conditions considered not eligible for the trial upon investigator's judgement
Sexes Eligible for Study: Male
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01736033
TMS1011
Yes
Not Provided
Not Provided
Soo Woong Kim, MD, Seoul National University Hospital
Seoul National University Hospital
  • Astellas Pharma Korea, Inc.
  • Medical Research Collaborating Center, Seoul, Korea
Principal Investigator: Soo Woong Kim, M.D. Seoul National University Hospital
Seoul National University Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP