Value through Innovation27 July 2016

Clinical Study Results

  • FLOMAX ® - Prostatic Hyperplasia
    Clinical Study Number 527.15
    Study Indication Prostatic Hyperplasia
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    MICTUS (Multicentre investigation to characterise the effect of Tamsulosin on Urinary Symptoms): A multicentre, double-blind, randomised, parallel group study, aimed at characterising the effect of tamsulosin, an uroselective alpha1-receptor blocking agent, on the urological symptoms and their impact on general heath status and quality of life in outpatients affected by symptoptomatic benign prostatic hyperplasia: comparison with finasteride.

    Study Document Trial synopsis 527.15 english
  • FLOMAX ® - Prostatic Hyperplasia
    Clinical Study Number 527.16
    Study Indication Prostatic Hyperplasia
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    A Forty-Five Day, Open-Label Study of the Symptomatic Relief Effects of FLOMAX® Capsules 0.4 mg Daily in Patients with the Signs and Symptoms of Benign Prostatic Hyperplasia

    Study Document Trial synopsis 527.16_CO english
  • FLOMAX ® - Prostatic Hyperplasia
    Clinical Study Number 527.17
    Study Indication Prostatic Hyperplasia
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    An Eleven-Week, Open-Label, Randomized, Multicenter, Parallel-Design, Placebo Lead-in Study ofFLOMAX® Capsules, 0.4 mg Daily Versus HYTRIN® Capsules, 5 mg (with Titration) Daily in Patients with the Signs and Symptoms of Benign Prostatic Hyperplasia

    Study Document Trial synopsis 527.17_CO english
  • FLOMAX ® - Prostatic Hyperplasia
    Clinical Study Number 527.20
    Study Indication Prostatic Hyperplasia
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    Effect of ALNA® (Tamsulosin) on the primary symptoms ofBPH (benign prostatic hyperplasia) syndrome

    Study Document Trial synopsis 527.20 english
  • FLOMAX ® - Lower Urinary Tract Symptoms
    Clinical Study Number 527.25
    Study Indication Lower Urinary Tract Symptoms
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase II
    Study Title

    An eight-week, double-blind, randomized, parallel group design, multicenter study of FLOMAX® capsules, 0.4 mg daily versus placebo, in female patients with lower urinary tract symptoms (LUTS) with a significant component of voiding symptoms

    Study Document Trial synopsis 527.25 english
  • FLOMAX ® - Prostatic Hyperplasia
    Clinical Study Number 527.26
    Study Indication Prostatic Hyperplasia
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase II
    Study Title

    A two phase, double-blinded, randomized, parallel-group design, multicenter study of FLOMAX® capsules 0.4 mg versus placebo in male patients with acute urinary retention related to benign prostatic hyperplasia

    Study Document Trial synopsis 527.26 english
  • FLOMAX ® - Prostatic Hyperplasia
    Clinical Study Number 527.28
    Study Indication Prostatic Hyperplasia
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    Evolution of patients suffering from Benign Prostatic Hyperplasia (BPH) treated with alpha-adrenergic blockade

    Study Document Trial synopsis 527.28 english
  • FLOMAX ® - Lower Urinary Tract Symptoms
    Clinical Study Number 527.30
    Study Indication Lower Urinary Tract Symptoms
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    BLADDER (BPH, LUTS And Detrusor: Dual Effect Research) study: A multicentre, double-blind, randomised, parallel group, placebo-controlled study, aimed at characterising the effect of tamsulosin on Lower Urinary Tract Symptoms (LUTS) and detrusor motor activity in patients affected by benign prostatic hyperplasia (BPH) and storage urinary symptoms.

    Study Document Trial synopsis 527.30_CO english
  • FLOMAX ® - Prostatic Hyperplasia
    Clinical Study Number 527.38
    Study Indication Prostatic Hyperplasia
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    Observational study in patients with functional BPH (Benign Prostatic Hyperplasia) who switched from Phytotherapy to Alna (Tamsulosin)

    Study Document Trial synopsis 527.38 english
  • FLOMAX ® - Prostatic Hyperplasia
    Clinical Study Number 527.40
    Study Indication Prostatic Hyperplasia
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    Comorbidity and Comedication during prescription of ALNA® (Tamsulosin) for patients with BPH (Benign Prostatic Hyperplasia)

    Study Document Trial synopsis 527.40 english
  • FLOMAX ® - Prostatic Hyperplasia
    Clinical Study Number 527.46
    Study Indication Prostatic Hyperplasia
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    Study of convergence responses to IPSS questionnaire in patients with benign prostatic hyperplasia, and their wives/partners

    Study Document Trial synopsis 527.46 english
  • FLOMAX ® - Urination Disorders
    Clinical Study Number 527.49
    Study Indication Urination Disorders
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics, safety, and tolerability of single oral doses (0.1, 0.2, 0.4 and 0.8 mg) of tamsulosin hydrochloride in children with voiding disorders

    Study Document Trial synopsis 527.49 english
  • FLOMAX ® - Prostatic Hyperplasia
    Clinical Study Number 527.56
    Study Indication Prostatic Hyperplasia
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    ALNA® -AWB in pre-treated patients with BPS

    Study Document Trial synopsis 527.56 english
  • FLOMAX ® - Prostatic Hyperplasia
    Clinical Study Number 527.57
    Study Indication Prostatic Hyperplasia
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    Study of convergence responses to IPSS and Socio questionnaires in patients treated for benign prostatic hyperplasia.

    Study Document Trial synopsis 527.57 english
  • FLOMAX ® - Prostatic Hyperplasia
    Clinical Study Number 527.58
    Study Indication Prostatic Hyperplasia
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    Secotex ®: Prescription Event Monitoring in patients with benign prostatic hyperplasia (BPH)

    Study Document Trial synopsis 527.58 english
  • FLOMAX ® - Prostatic Hyperplasia
    Clinical Study Number 527.64
    Study Indication Prostatic Hyperplasia
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    Secotex ®: Prescription Event Monitoring in patients with benign prostatic hyperplasia (BPH)

    Study Document Trial synopsis 527.64 english
  • FLOMAX ® - Lower Urinary Tract Symptoms
    Clinical Study Number 527.68
    Study Indication Lower Urinary Tract Symptoms
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    The Impact of Alna® Ocas® on Nocturia in patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH)

    Study Document Trial synosis 527.68 english
  • FLOMAX ® - Healthy
    Clinical Study Number 527.70
    Study Indication Healthy
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase I
    Study Title

    A parallel group study with three different ?-antagonists and placebo once daily over three weeks to assess their influence on the extent of weekly phenylephrine induced mydriasis at three different concentrations of phenylephrine in healthy male volunteers

    Study Document Trial synopsis 527.70 english
  • FLOMAX ® - Prostatic Hyperplasia
    Clinical Study Number 527.73
    Study Indication Prostatic Hyperplasia
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    Observational study about the use of tamsulosin in patients with benign prostatic hyperplasia

    Study Document Trial synopsis 527.73 english
  • FLOMAX ® - Healthy
    Clinical Study Number 527.78
    Study Indication Healthy
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase I
    Study Title

    An open label randomized two-way crossover study to investigate the effect of ketoconazole mediated CYP3A4 inhibition on the single oral dose pharmacokinetics of tamsulosin in healthy male volunteers (CYP2D6 extensive metabolizers).

    Study Document Trial synopsis 527.78 english
  • FLOMAX ® - Healthy
    Clinical Study Number 527.79
    Study Indication Healthy
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase I
    Study Title

    An open label randomized two-way crossover study to investigate the effect ofparoxetine mediated CYP2D6 inhibition on the single oral dosepharmacokinetics of tamsulosin in healthy male volunteers (CYP2D6 extensivemetabolizers).

    Study Document Trial synopsis 527.79 english
  • FLOMAX ® - Prostatic Hyperplasia
    Clinical Study Number 527.80
    Study Indication Prostatic Hyperplasia
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IV
    Study Title

    Quality of life in patients with BPH and nocturia before and after tamsulosin Ocas® treatment

    Study Document Trial synopsis 527.80_DR english
  • FLOMAX ® - Urinary Bladder, Neurogenic
    Clinical Study Number 527.51
    Study Indication Urinary Bladder, Neurogenic
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase IIb/III
    Study Title

    A Phase IIb/III, multi-centre, double-blind, randomised, placebo-controlled, dose ranging study of tamsulosin hydrochloride (low, medium and high dose) as treatment in children with neuropathic bladder for three months

    Study Document Trial synopsis 527.51_DS_DR english
  • FLOMAX ® - Urinary Bladder, Neurogenic
    Clinical Study Number 527.66
    Study Indication Urinary Bladder, Neurogenic
    Product FLOMAX ®
    Generic Name Tamsulosin
    Lab Code
    Clinical Phase II
    Study Title

    An uncontrolled, open-label, titration, long-term safety (up to 12 months) and efficacy study of tamsulosin hydrochloride in children with neuropathic bladder, with a randomized pharmacokinetic sub-study investigating low, medium and high dose ranges

    Study Document Trial synopsis 527.66_GR_D_Denovo_DS_DR english Trial synopsis 527.66_GR_D_Rollover_DS_DR english Trial synopsis 527.66_Prim_endp english

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