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Post-Marketing Surveillance of Micardis® (Telmisartan) in Patients With Hypertension

Completed
Conditions
Hypertension
Interventions
Registration Number
NCT02242838
Lead Sponsor
Boehringer Ingelheim
Brief Summary

The primary objective of this survey is to prospectively investigate safety and efficacy in patients with hypertension treated with telmisartan in proper use in medical practice over a long period

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
6336
Inclusion Criteria
  • Patients with hypertension
Exclusion Criteria

Patients with the following conditions

  • Patients with a history of hypersensitivity of this product
  • Women in pregnancy (included the possibility of pregnancy)
  • Patients with severe biliary obstructive disorders or severe hepatic insufficiency

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Hypertensive patientsTelmisartan-
Primary Outcome Measures
NameTimeMethod
Change in Mean systolic blood pressure (SBP)up to 1 year
Number of patients with adverse drug reactionsup to 1 year
Change in Mean diastolic blood pressure (DBP)up to 1 year
Incidence of adverse drug reactionsup to 1 year

classified by Medical Dictionary for Regulatory Activities (MedDRA) terminology

Secondary Outcome Measures
NameTimeMethod
Overall assessment of efficacy by investigator on 4-point scaleat 3 month, after 1 year
Change in pulse rateup to 1 year
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