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

September 18, 2014 updated by: Boehringer Ingelheim

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

13066

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with essential hypertension and without prior Micardis experience

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with essential hypertension
Drug: Telmisartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure reduction
Time Frame: Up to 6 years
Up to 6 years
Final assessment of efficacy on a 3-point scale
Time Frame: Up to 6 years
Up to 6 years
Assessment of efficacy based on subject's demographics on a two-point scale
Time Frame: Up to 6 years
Up to 6 years
Number of patients with adverse events
Time Frame: Up to 6 years
Up to 6 years
Incidence rate of adverse events
Time Frame: Up to 6 years
based on demographic factors
Up to 6 years
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
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Primary Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 18, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.479

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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