Post-marketing Surveillance Study With MicardisPlus® in Treatment of Morning Hypertension (Self-monitored by Patient)

September 16, 2014 updated by: Boehringer Ingelheim

Morning Hypertension and Patient Self-monitoring

The purpose of the study was to examine the effect of six- to eight-week treatment with MicardisPlus® on blood pressure and the effect of patient self-monitoring on blood pressure control. In addition, the post-marketing surveillance study offered the possibility to obtain information about the influence on different laboratory parameters during treatment with MicardisPlus® from an unselected patient group under office conditions

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2707

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 essential hypertension

Description

Inclusion Criteria:

  • Age > 18 years
  • Hypertension

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Essential hypertension
Drug: MicardisPlus®
Other Names:
  • Telmisartan in combination with hydrochlorothiazide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in morning blood pressure (systolic and diastolic)
Time Frame: Pre-dose, up to 8 weeks after start of treatment
Pre-dose, up to 8 weeks after start of treatment
Changes from baseline in laboratory values
Time Frame: Pre-dose, up to 8 weeks after start of treatment
Pre-dose, up to 8 weeks after start of treatment
Investigator assessment of efficacy on a 5-point scale
Time Frame: Up to 8 weeks after start of treatment
Up to 8 weeks after start of treatment
Investigator assessment of influence on metabolism on a 3-point scale
Time Frame: Up to 8 weeks after start of treatment
Up to 8 weeks after start of treatment
Investigator assessment of tolerability on a 5-point scale
Time Frame: Up to 8 weeks after start of treatment
Up to 8 weeks after start of treatment
Number of patients with adverse events
Time Frame: Up to 8 weeks
Up to 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, 2006

Primary Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 16, 2014

First Posted (Estimate)

September 18, 2014

Study Record Updates

Last Update Posted (Estimate)

September 18, 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

  • 502.513

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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