Investigating the Effect of Telmisartan (Micardis®) on the Average 24h Blood Pressure of Therapy-naive and Therapy-experienced Patients

February 28, 2014 updated by: Boehringer Ingelheim

24h BP Under Micardis in Daily Practice

Practical experience report (PER) investigating the effect of Micardis® on the average 24h blood pressure of therapy-naive and therapy-experienced patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

670

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 to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hypertensive patients

Description

Inclusion criteria:

  1. Patients who have recently been diagnosed with hypertension
  2. Patients whose current blood pressure treatment are inadequate and needs to be revised are suitable for inclusion.

Exclusion criteria:

None (according to investigator)

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
arterial hypertension
Drug: Micardis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy (Change of Systolic Blood Pressure)
Time Frame: baseline to 8 weeks
Change from baseline in 24h systolic blood pressure (BP) at week 8
baseline to 8 weeks
Efficacy (Change of Diastolic Blood Pressure)
Time Frame: baseline to 8 weeks
Change from baseline in 24h diastolic blood pressure (BP) at week 8
baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Tolerability Scale
Time Frame: 8 weeks
Safety and tolerability of Micardis® in the treatment of patients with hypertension over 8 weeks, using 10 point Likert scale with worst score=1, best score=10
8 weeks

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

April 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

April 9, 2009

First Submitted That Met QC Criteria

April 9, 2009

First Posted (Estimate)

April 10, 2009

Study Record Updates

Last Update Posted (Estimate)

March 28, 2014

Last Update Submitted That Met QC Criteria

February 28, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.582

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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