Post Marketing Surveillance (PMS) Study to Assess Safety and Efficacy of Micardis in Patients With Essential Hypertension

Boehringer Ingelheim13,066 enrolled

Overview

The objective of this PMS study was to monitor and assess the safety of Micardis tablets in patients with hypertension over a period of 6 years

Study Type

OBSERVATIONAL

Enrollment

13,066

Conditions

Hypertension

Interventions

TelmisartanDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients diagnosed with essential hypertension * Patients without prior experience with Micardis tablet Exclusion Criteria: * Known hypersensitivity to Micardis tablet * Pregnancy or breastfeeding * Biliary atresia * Severe hepatic failure patients * Severe renal failure patients

Outcomes

Primary Outcomes

Blood pressure reduction

Time frame: Up to 6 years

Final assessment of efficacy on a 3-point scale

Time frame: Up to 6 years

Assessment of efficacy based on subject's demographics on a two-point scale

Time frame: Up to 6 years

Number of patients with adverse events

Time frame: Up to 6 years

Incidence rate of adverse events

based on demographic factors

Time frame: Up to 6 years

Assessment of safety on a 4-point scale

based on adverse events and changes in abnormality of clinical laboratory tests

Time frame: Up to 6 years

Data from ClinicalTrials.gov

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