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

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

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telmisartan

Drug

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

Time frame: Up to 6 years

based on demographic factors
Assessment of safety on a 4-point scale

Time frame: Up to 6 years

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start: 2000
Primary completion: 2006
First posted: Sep 19, 2014
Registry last updated: Sep 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed