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

The Post Marketing Surveillance Study Conducted With a Continuous Enrollment Method to Assess Serious Adverse Events, Adverse Events, Safety, Efficacy of Micardis Tablet (Telmisartan 20, 40, 80mg p.o. Once Daily Over 2 Weeks)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02245464

Enrollment

13066

Registered

2014-09-19

Start date

2000-11-30

Completion date

Unknown

Last updated

2014-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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

Interventions

DRUGTelmisartan

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Blood pressure reduction	Up to 6 years	—
Final assessment of efficacy on a 3-point scale	Up to 6 years	—
Assessment of efficacy based on subject's demographics on a two-point scale	Up to 6 years	—
Number of patients with adverse events	Up to 6 years	—
Incidence rate of adverse events	Up to 6 years	based on demographic factors
Assessment of safety on a 4-point scale	Up to 6 years	based on adverse events and changes in abnormality of clinical laboratory tests

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026