Post-Marketing Surveillance of Micardis® (Telmisartan) in Patients With Hypertension

September 16, 2014 updated by: Boehringer Ingelheim

Post-Marketing Surveillance of Micardis® (Telmisartan) Special Drug Use-results Survey on Long-term Treatment

The primary objective of this survey is to prospectively investigate safety and efficacy in patients with hypertension treated with telmisartan in proper use in medical practice over a long period

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6336

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

Hypertension patients without telmisartan treatment are selected at medical institutions

Description

Inclusion Criteria:

  • Patients with hypertension

Exclusion Criteria:

Patients with the following conditions

  • Patients with a history of hypersensitivity of this product
  • Women in pregnancy (included the possibility of pregnancy)
  • Patients with severe biliary obstructive disorders or severe hepatic insufficiency

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
Hypertensive patients
Drug: Telmisartan
Other Names:
  • Micardis®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse drug reactions
Time Frame: up to 1 year
up to 1 year
Incidence of adverse drug reactions
Time Frame: up to 1 year
classified by Medical Dictionary for Regulatory Activities (MedDRA) terminology
up to 1 year
Change in Mean systolic blood pressure (SBP)
Time Frame: up to 1 year
up to 1 year
Change in Mean diastolic blood pressure (DBP)
Time Frame: up to 1 year
up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall assessment of efficacy by investigator on 4-point scale
Time Frame: at 3 month, after 1 year
at 3 month, after 1 year
Change in pulse rate
Time Frame: up to 1 year
up to 1 year

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

September 1, 2003

Primary Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 16, 2014

First Posted (Estimate)

September 17, 2014

Study Record Updates

Last Update Posted (Estimate)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.500

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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