Post-Marketing Surveillance Study of Micardis® Plus in Patients With Hypertension

September 11, 2014 updated by: Boehringer Ingelheim

Post-Marketing Surveillance Study Micardis® Plus

Study to evaluate efficacy and tolerability of Micardis® plus under usual daily-practice prescribing-conditions

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8135

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

Outpatients with hypertension

Description

Inclusion Criteria:

  • Adult (Age >= 18 years) males and females for whom a medical antihypertensive therapy is indicated

Exclusion Criteria:

  • Age < 18 years

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
Patients with hypertension
Drug: Micardis® plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in morning blood pressure
Time Frame: Baseline, after 6 weeks
Baseline, after 6 weeks
Change from baseline in classification of blood pressure
Time Frame: Baseline, after 6 weeks
according to Word Health Organisation - Isolated systolic hypertension (WHO-ISH) - definition of 'Deutsche Hochdruckliga'
Baseline, after 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse drug reactions
Time Frame: up to 6 weeks
up to 6 weeks
Assessment of tolerability by investigator on a 5-point scale
Time Frame: after 6 weeks
after 6 weeks
Assessment of efficacy by investigator on 5-point scale
Time Frame: after 6 weeks
after 6 weeks
Change from baseline in heart rate
Time Frame: Baseline, after 6 weeks
Baseline, after 6 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

June 1, 2002

Primary Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 11, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.390

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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