Value through Innovation27 July 2016

Clinical Study Results

  • MICATRIO ® - Hypertension
    Clinical Study Number 1348.2
    Study Indication Hypertension
    Product MICATRIO ®
    Generic Name Telmisartan + Amlodipine + Hydrochlorothiazide
    Lab Code
    Clinical Phase III
    Study Title

    An eight-week randomised double-blind study to compare the efficacy and safety of telmisartan 80 mg and amlodipine 5 mg and hydrochlorothiazide 12.5 mg vs. telmisartan 80 mg and hydrochlorothiazide 12.5 mg in patients with hypertension who fail to respond adequately to treatment with telmisartan 80 mg and hydrochlorothiazide 12.5 mg, followed by a 52-week extension study to assess long-term safety of telmisartan 80 mg andamlodipine 5 mg and hydrochlorothiazide 12.5 mg

    Study Document Trial synopsis 1348.2_DR english
  • MICATRIO ® - Hypertension
    Clinical Study Number 1348.1
    Study Indication Hypertension
    Product MICATRIO ®
    Generic Name Telmisartan + Amlodipine + Hydrochlorothiazide
    Lab Code
    Clinical Phase III
    Study Title

    An eight-week randomised double-blind study to compare the efficacy and safety of telmisartan 80 mg and amlodipine 5 mg and hydrochlorothiazide12.5 mg vs. telmisartan 80 mg and amlodipine 5 mg in patients with hypertension who fail to respond adequately to treatment with telmisartan 80 mg and amlodipine 5 mg

    Study Document Trial synopsis 1348.1_DR english
  • MICATRIO ® - Healthy
    Clinical Study Number 1348.3
    Study Indication Healthy
    Product MICATRIO ®
    Generic Name Telmisartan + Amlodipine + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of telmisartan 80 mg/amlodipine 5 mg/hydrochlorothiazide 12.5 mg fixed-dose combination tablet compared to concomitant administration of telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablet and hydrochlorothiazide 12.5 mg tablet in healthy male subjects: an open-label, randomised, single-dose, two-sequence, four-period replicated crossover study

    Study Document Trial synopsis 1348.3 english
  • MICATRIO ® - Healthy
    Clinical Study Number 1348.4
    Study Indication Healthy
    Product MICATRIO ®
    Generic Name Telmisartan + Amlodipine + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of telmisartan 80 mg/amlodipine 5 mg/hydrochlorothiazide 12.5 mg fixed-dose combination tablet compared to concomitant administration of telmisartan 80 mg/hydrochlorothiazide 12.5 mg fixed-dose combination tablet and amlodipine 5 mg capsule in healthy male subjects (an open-label, randomised, single-dose, two-sequence, four-period replicated crossover study), with influence of food on the bioavailability of telmisartan 80 mg/amlodipine 5 mg/hydrochlorothiazide 12.5 mg fixed-dose combination tablet

    Study Document Trial synopsis 1348.4 english
  • MICATRIO ® - Healthy
    Clinical Study Number 1348.5
    Study Indication Healthy
    Product MICATRIO ®
    Generic Name Telmisartan + Amlodipine + Hydrochlorothiazide
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics of multiple oral doses of telmisartan 80 mg/amlodipine 5 mg /hydrochlorothiazide 12.5 mg fixed-dose combination tablet, telmisartan 80 mg/ hydrochlorothiazide 12.5 mg fixed-dose combination tablet and telmisartan 80 mg/ amlodipine 5 mg fixed-dose combination tablet at steady state in healthy male subjects: an open-label, randomised, multiple-dose, three-treatment, three-period, six-sequence crossover study

    Study Document Trial synopsis 1348.5 english

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