Study Describing the Hypertensive Population Treated With Telmisartan and Conditions of Use by Medical Practitioners and Patients

September 16, 2014 updated by: Boehringer Ingelheim

Pharmaco-epidemiological Study Describing the Hypertensive Population Treated With Telmisartan and Conditions of Use by Medical Practitioners and Patients

Primary objective: to characterize hypertensive patients treated for at least 1 month with Telmisartan (alone or in combination with other drugs) in order to define the beneficiary population (those actually receiving the treatment).

Secondary objectives:

  • to describe the patients' blood pressure values (when self-monitored) and satisfaction with the treatment (ease of use, efficacy, safety) on the basis of a patient self-questionnaire, filled out 4 weeks after consultation.
  • to compare the characteristics of the beneficiary population to those of the initial target population defined in the SPC (summary of product characteristics) for Telmisartan

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5018

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

21 years to 94 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hypertensive patients treated with Telmisartan for at least one month recruited by ceneral practitioners and cardiologists

Description

Inclusion Criteria:

  • Hypertensive patients treated with Telmisartan for at least one month, consulting a medical practitioner (for whatever reason)

Exclusion Criteria:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characteristics of hypertensive patients
Time Frame: Baseline, after 1 month of treatment
Questionnaire to determine the beneficiary population
Baseline, after 1 month of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in blood pressure
Time Frame: Up to 1 month
Self-monitored by patient
Up to 1 month
Evaluation of patients satisfaction with treatment
Time Frame: Up to 1 month
Based on a patient 6-point self-questionnaire
Up to 1 month

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, 2004

Primary Completion (Actual)

May 1, 2005

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

  • 502.450

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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