Evaluation of Efficacy and Tolerability of Micardis® / MicardisPlus® Under Usual Daily-practice Prescribing in Patients With Hypertension

September 16, 2014 updated by: Boehringer Ingelheim

Morning Hypertension and Monitoring of Metabolism (AWB Morgenhochdruck & Stoffwechselmonitoring)

To evaluate efficacy and tolerability of Micardis® / MicardisPlus® under usual daily-practice prescribing conditions with a special emphasis on controlling morning blood pressure

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

13248

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, insufficiently treated 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: Telmisartan
Drug: Telmisartan in combination with hydrochlorothiazide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in morning blood pressure (BP)
Time Frame: Pre-dose, up to 6 months after start of treatment
Pre-dose, up to 6 months after start of treatment
Changes in metabolic laboratory parameters
Time Frame: Pre-dose, up to 6 months after start of treatment
Pre-dose, up to 6 months after start of treatment
Changes in morning blood pressure in patients with or without telemonitoring (TM) of BP
Time Frame: Pre-dose, up to 6 months after start of treatment
Pre-dose, up to 6 months after start of treatment
Investigator assessment of efficacy in reducing morning hypertension on a 5-point rating scale
Time Frame: Up to 6 months after start of treatment
Up to 6 months after start of treatment
Investigator assessment of effects on metabolism on a 3-point rating scale
Time Frame: Up to 6 months after start of treatment
Up to 6 months after start of treatment
Investigator assessment of tolerability on a 5-point rating scale
Time Frame: Up to 6 months after start of treatment
Up to 6 months after start of treatment
Number of patients with adverse events
Time Frame: Up to 6 months
Up to 6 months
Changes in morning heart rate
Time Frame: Pre-dose, up to 6 months after start of treatment
Pre-dose, up to 6 months after start of treatment

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, 2005

Primary Completion (Actual)

October 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

  • 502.485

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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