Safety, Tolerability and Efficacy of Micardis® in Patients With Essential Hypertension

July 7, 2014 updated by: Boehringer Ingelheim

Safety, Tolerability and Efficacy of Micardis® (Telmisartan) in Patients With Essential Hypertension

This post-marketing surveillance study was designed to supplement under conditions of normal clinical practice the data on the safety, tolerability and efficacy of Micardis® collected during the clinical studies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19870

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of general practioners, cardiologists and specialist in internal medicine in non-hospital practice

Description

Inclusion Criteria:

  • Patients of both sexes with essential hypertension and a minimum age of 18 years

Exclusion Criteria: (Not applicable)

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
Micardis®
Drug: Micardis®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Indicence of ulcera
Time Frame: Up to 6 months after start of study
Up to 6 months after start of study
Incidence of gastrointestinal (GI) bleedings
Time Frame: Up to 6 months after start of study
Up to 6 months after start of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (GI-complaints inclusive)
Time Frame: Up to 6 months after start of study
Up to 6 months after start of study
Change from baseline in office blood pressure
Time Frame: Up to 6 months after start of study
Up to 6 months after start of study
Response rate
Time Frame: Up to 6 months after start of study
full response: reduction of diastolic blood pressure (DBP) by >= 10 mmHg or final DBP <= 90 mmHg overall response: reduction of DBP by >= 7mmHg or final DBP <= 90 mmHg
Up to 6 months after start of study

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

January 1, 1999

Primary Completion (Actual)

May 1, 2000

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

June 26, 2014

First Posted (Estimate)

June 27, 2014

Study Record Updates

Last Update Posted (Estimate)

July 8, 2014

Last Update Submitted That Met QC Criteria

July 7, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.314

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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