Post Marketing Surveillance Study in Rehabilitation Clinics (Cardio, Nephro, Diabetes, Pulmo)

October 10, 2014 updated by: Boehringer Ingelheim
Study to obtain long-term data on effects, safety and tolerability in routine medical practice and to investigate the potential of telmisartan to prevent secondary organ damage

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

266

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 with hypertension recruited at hospitals in Germany specialized in cardiology, nephrology, diabetology and pneumology

Description

Inclusion Criteria:

  • Adult patients of both gender aged >=18 admitted to a hospital due to insufficiently controlled essential hypertension.

No additional selection criteria have to be considered. Treatment was at the discretion of the physician following the summary of product information for Micardis® and MicardisPlus®

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
Hypertension patients - Pneumology
Drug: Micardis®
Drug: MicardisPlus®
Hypertension patients - Cardiology
Drug: Micardis®
Drug: MicardisPlus®
Hypertension patients - Nephrology
Drug: Micardis®
Drug: MicardisPlus®
Hypertension patients - Diabetology
Drug: Micardis®
Drug: MicardisPlus®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse events
Time Frame: up to 1 year
up to 1 year
Number of patients with abnormal changes in laboratory parameters
Time Frame: up to 1 year
up to 1 year
Number of patients with clinically significant changes in vital signs
Time Frame: up to 1 year
up to 1 year
Change in systolic blood pressure
Time Frame: up to 1 year
up to 1 year
Change in diastolic blood pressure
Time Frame: up to 1 year
up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Global assessment of efficacy by investigator on a 4-point scale
Time Frame: 2 weeks, after 1 year
2 weeks, after 1 year
Global assessment of tolerability by investigator on a 4-point scale
Time Frame: 2 weeks, after 1 year
2 weeks, after 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

January 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Estimate)

October 13, 2014

Last Update Submitted That Met QC Criteria

October 10, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.428
  • 502.429, 502.430, 502.431 (Other Identifier: Boehringer Ingelheim)

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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