Value through Innovation27 July 2016

Clinical Study Results

  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.41
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase I
    Study Title

    A Single-Dose, Comparative Bioavailability Study of Telmisartan/Amlodipine 80 mg/10 mg Tablets versus Micardis 80 mg Tablets with Norvasc 10 mg Tablets under Fasting Conditions

    Study Document Trial synopsis 1235.41 english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.5
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    An eight-week randomised, 4-arm, double-blind study to compare the efficacy and safety of combinations of telmisartan 40 mg + amlodipine 5 mg versus telmisartan 80 mg + amlodipine 5 mg versus amlodipine 5 mg monotherapy versus amlodipine 10 mg monotherapy in patients with hypertension who fail to respond adequately to treatment with amlodipine 5 mg monotherapy.Telmisartan plus Amlodipine Study in Amlodipine 5 mg Non-Responders in Hypertension: TEAMSTA-5

    Study Document Trial synopsis 1235.5_DR english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.1
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    A randomized, double-blind, double-dummy placebo-controlled, 4x4 factorial design trial to evaluate telmisartan 20, 40 and 80 mg tablets in combination with amlodipine 2.5, 5 and 10 mg capsules after eight weeks of treatment in patients with Stage I or II hypertension, with an ABPM sub-study

    Study Document Trial synopsis 1235.1_DR english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.21
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    TElmisartan 80 mg plus AMlodipine 10 mg fixed-dose combination tablet STudy versus Amlodipine 10 mg over-encapsulated tablets as first line therapy in patients with Type 2 Diabetes Mellitus and Stage 1 or 2 hypertension: a Phase III, eight week, randomised, double-blind, double-dummy, forced titration comparison with an ABPM sub-study

    Study Document Trial synopsis 1235.21_DS_CO english
  • TWYNSTA ® - Healthy
    Clinical Study Number 1235.30
    Study Indication Healthy
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase I
    Study Title

    A single-centre, randomized, open-label, three-period crossover pharmacokinetic study of 80 mg telmisartan / 5 mg amlodipine fixed dose combination compared with its monocomponents in healthy Chinese subjects

    Study Document Trial synopsis 1235.30_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.6
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    An eight-week randomised, 3-arm, double-blind study to compare the safety and efficacy of the combination of telmisartan 40 mg + amlodipine 10 mg versus telmisartan 80 mg + amlodipine 10 mg versus amlodipine 10 mg monotherapy in patients with hypertension who fail to respond adequately to treatment with amlodipine 10 mg monotherapy.Telmisartan plus Amlodipine Study in Amlodipine 10 mg Non-Responders in Hypertension: TEAMSTA-10

    Study Document Trial synopsis 1235.6_DR english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.7
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    An open label follow-up trial of the efficacy and safety of chronic administration of the combination of telmisartan 40 mg + amlodipine 5 mg or the combination of telmisartan 80 mg + amlodipine 5 mg tablets alone or in combination with other antihypertensive medications in patients with hypertension

    Study Document Trial synopsis 1235.7_DR english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.8
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    An open-label follow-up trial of the efficacy and safety of chronic administration of the combination of telmisartan 40 mg + amlodipine 10 mg or the combination of telmisartan 80 mg + amlodipine 10 mg tablets alone or in combination with other antihypertensive medications in patients with hypertension

    Study Document Trial synopsis 1235.8_DR english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.13
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind trial to compare telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination to amlodipine 5 mg monotherapy in patients not controlled with amlodipine 5 mg monotherapy

    Study Document Trial synopsis 1235.13_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.14
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    A randomised, double-blind trial to compare telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination to telmisartan 40 mg monotherapy in patients not controlled with telmisartan 40 mg monotherapy

    Study Document Trial synopsis 1235.14_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.16
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    An open-label, long-term study of telmisartan plus amlodipine fixed-dose combination (telmisartan 40 mg/amlodipine 5 mg and telmisartan 80 mg/amlodipine 5 mg) to evaluate 1-year long-term safety and efficacy in the patients with essential hypertension

    Study Document Trial synopsis 1235.16_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.20
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    TElmisartan 80 mg plus AMlodipine 10 mg fixed-dose combination tabletSTudy versus Amlodipine 10 mg over encapsulated tablets or telmisartan 80 mg tablets as first line therapy in patients with severe HyperTensioN: A Phase III 8-week, randomised, double-blind, double-dummy, forced-titration comparison (TEAMSTA severe HTN)

    Study Document Trial synopsis 1235.20_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.33
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase IIIb
    Study Title

    Prospective, open label TElmisartan/AMlodipine single pill STudy to Assess the efficacy in patients with essential hypertension who are not controlled on RAASi mono-therapy being switched TEAMSTA switch

    Study Document Trial synopsis 1235.33_DR english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.36
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase IIIa
    Study Title

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

    Study Document Trial synopsis 1235.36_DS_CO english
  • TWYNSTA ® - Healthy
    Clinical Study Number 1235.28
    Study Indication Healthy
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of telmisartan administrated in two different ways: both in   telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablet and   telmisartan 80 mg tablet and amlodipine 5 mg tablet in concomitant use in   healthy male volunteers. (an open-label, randomised, single-dose, four-period   replicated crossover study)

    Study Document Trial synopsis 1235.28_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.31
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase III
    Study Title

    An open-label study to evaluate the antihypertensive effects of the fixed-dose combination of telmisartan 80 mg and amlodipine 5 mg (T80/A5) given once daily by 24-h ABPM in patients with moderate to severe hypertension

    Study Document Trial synopsis 1235.31_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.29
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase IIIa
    Study Title

    An eight-week randomized, double-blind, multicentre study to evaluate the efficacy and safety of fixed-dose combinations of telmisartan 80 mg plus amlodipine 5 mg versus amlodipine 5 mg monotherapy in patients with hypertension who fail to respond adequately to treatment with amlodipine 5 mg monotherapy

    Study Document Trial synopsis 1235.29_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.37
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase IIIa
    Study Title

    An eight-week randomised double-blind study to compare the efficacy and safety of telmisartan 80 mg plus amlodipine 5 mg fixed-dose combination vs. telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination in patients with hypertension

    Study Document Trial synopsis 1235.37_DS_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.38
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase IV
    Study Title

    Survey on Drug Use of Micamlo® Combination Tablets AP in Patients with Hypertension

    Study Document Trial synopsis 1235.38_DR english
  • TWYNSTA ® - Healthy
    Clinical Study Number 1235.12
    Study Indication Healthy
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase I
    Study Title

    Influence of food on the bioavailability of 80 mg telmisartan/10 mg amlodipine fixed dose combination in healthy male and female volunteers. An open-label, randomised, single-dose, two-period crossover study

    Study Document Trial synopsis 1235.12_CO english
  • TWYNSTA ® - Healthy
    Clinical Study Number 1235.17
    Study Indication Healthy
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of telmisartan 40 mg/amlodipine 5 mg fixed-dose combination tablet compared to concomitant use of its mono-components (i.e.,telmisartan 40 mg tablet and amlodipine 5 mg tablet in concomitant use) following oral administration in healthy male volunteers (an open-label,randomised, single-dose, two-way crossover study)

    Study Document Trial synopsis 1235.17_CO english
  • TWYNSTA ® - Healthy
    Clinical Study Number 1235.18
    Study Indication Healthy
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase I
    Study Title

    Relative bioavailability of telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablet compared to concomitant use of its mono-components (i.e.,two telmisartan 40 mg tablets and amlodipine 5 mg tablet in concomitant use) following oral administration in healthy male volunteers (an open-label,randomised, single-dose, two-way crossover study)

    Study Document Trial synopsis 1235.18_CO english
  • TWYNSTA ® - Healthy
    Clinical Study Number 1235.2
    Study Indication Healthy
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase I
    Study Title

    Pharmacokinetics of repeated oral doses of 80 mg telmisartan (Micardis®) at steady state alone and in combination with repeated oral doses of amlodipine 10 mg (Norvasc®) at steady state. A twoway crossover, open, randomised design study.

    Study Document Trial synopsis 1235.2 english
  • TWYNSTA ® - Healthy
    Clinical Study Number 1235.27
    Study Indication Healthy
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase I
    Study Title

    Influence of food on the bioavailability of telmisartan 40 mg/amlodipine 5 mg fixed-dose combination and of telmisartan 80 mg/amlodipine 5 mg fixed-dose combination in healthy Japanese male volunteers (a phase I, open-label,randomised, single-dose, two-way crossover trial)

    Study Document Trial synopsis 1235.27_CO english
  • TWYNSTA ® - Healthy
    Clinical Study Number 1235.3
    Study Indication Healthy
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of 40 mg telmisartan/5 mg amlodipine fixed dose combination compared with its monocomponents in healthy male and female volunteers. An open-label, randomised, single-dose, two-period crossover study

    Study Document Trial synopsis 1235.3_CO english
  • TWYNSTA ® - Healthy
    Clinical Study Number 1235.4
    Study Indication Healthy
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase I
    Study Title

    Bioequivalence of 80 mg telmisartan / 10 mg amlodipine fixed dose combination compared with its monocomponents in healthy male and female volunteers. An open-label, randomised, single-dose, two-sequence, two-period crossover study

    Study Document Trial synopsis 1235.4 english
  • TWYNSTA ® - Healthy
    Clinical Study Number 1235.9
    Study Indication Healthy
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase I
    Study Title

    Safety, tolerability and pharmacokinetics of single and multiple oral doses of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5 mg amlodipine (free dose combination) in healthy male volunteers

    Study Document Trial synopsis 1235.9_CO english
  • TWYNSTA ® - Hypertension
    Clinical Study Number 1235.40
    Study Indication Hypertension
    Product TWYNSTA ®
    Generic Name Telmisartan + Amlodipine
    Lab Code
    Clinical Phase IV
    Study Title

    A Regulatory Requirement Post-Marketing Surveillance Study to monitor the Safety and Efficacy of Twynsta (Telmisartan + Amlodipine SPC, q.d.) in Korean Hypertensive Patients Requiring Combination Therapy

    Study Document Trial synopsis 1235.40_PR english

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