The special drug use-results survey on long-term use of telmisartan 80 mg/amlodipine 5 mg/hydrochlorothiazide 12.5 mg fixed dose combination tablets in Patients with Hypertension in Japan (Japanese Micatrio PMS, long term)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Non-interventional, prospective, observational, single arm

Study drug and medical condition

• Medicinal product name, other:
  Micatrio® Combination Tablets
• Medical condition to be studied:
  Hypertension

Population studied

• Short description of the study population:
  Patients who diagnosed with hypertension based upon the most recent JSH guideline.; Inclusion criteria; - Patients who are prescribed with Micatrio® Combination Tablets by the discretion of investigators based on the Japanese package insert; - Patients who have never been treated with Micatrio® Combination Tablets before enrolment
• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  500

Study design details

• Study design:
  Non-interventional study based on newly collected data. The study consisted of a baseline visit and follow up visits at Weeks 4, 8, 12, 24, 36, and 52 for patients who had newly initiated Micatrio® Combination Tablets. The patients were followed up until discontinuation of Micatrio® Combination Tabs
• Main study objective:
  Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio® Combination Tablets treatment in patients with hypertension
• Outcomes:
  The frequency of patients with any suspected adverse drug reactions (ADRs), change from baseline in blood pressure at Week 52.
• Data analysis plan:
  Descriptive statistics will be summarized for safety and efficacy. Incidence of adverse drug reactions.Change from baseline in blood pressure at Week 52.Subgroup analyses.