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CompletedNCT02245464Updated Sep 19, 2014

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

An observational study in Hypertension, sponsored by Boehringer Ingelheim. Completed. Per ClinicalTrials.gov, last updated 2014-09-19.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
13,066
Sex
All
01

Study 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

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 13,066 is above the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with essential hypertension and without prior Micardis experience

Inclusion criteria

  • Male and female patients diagnosed with essential hypertension
  • Patients without prior experience with Micardis tablet

Exclusion criteria

Exclusion Criteria:

  • Known hypersensitivity to Micardis tablet
  • Pregnancy or breastfeeding
  • Biliary atresia
  • Severe hepatic failure patients
  • Severe renal failure patients
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
13,066 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with essential hypertension

    Drug: Telmisartan

Interventions

  • DrugTelmisartan
06

What researchers measure

Primary outcomes

  1. Blood pressure reduction

    Time frame: Up to 6 years

  2. Final assessment of efficacy on a 3-point scale

    Time frame: Up to 6 years

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

    Time frame: Up to 6 years

  4. Number of patients with adverse events

    Time frame: Up to 6 years

  5. Incidence rate of adverse events

    based on demographic factors

    Time frame: Up to 6 years

  6. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02245464
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Sep 19, 2014
Start date
Nov 2000
Primary completion
Nov 2006
Last update
Sep 19, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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