Study to Evaluate the Effect of the Treatment With Micardis® or MicardisPlus® on Blood Pressure

September 16, 2014 updated by: Boehringer Ingelheim

Micardis® / MicardisPlus® Monitoring of Morning Hypertension and Metabolism II

The primary objective was to evaluate the effect of the treatment with Micardis® or MicardisPlus® on blood pressure. Secondary objectives were the effect of Micardis® / MicardisPlus® on metabolic parameters (triglycerides, cholesterol, LDL blood glucose, insulin Homeostasis Model Assessment (HOMA)-index and HbA1c) in patients with essential hypertension and diabetes mellitus

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1527

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 and diabetes mellitus

Description

Inclusion Criteria:

  • Age > 18 years
  • Hypertension
  • Diabetes mellitus

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 and diabetes mellitus
Drug: Micardis®
Drug: MicardisPlus®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in systolic blood pressure (SBP)
Time Frame: Baseline, after 6 months
Baseline, after 6 months
Change from Baseline in diastolic blood pressure (DBP)
Time Frame: Baseline, after 6 months
Baseline, after 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse events
Time Frame: up to 6 months
up to 6 months
Assessment of efficacy by investigator on a 6-point scale
Time Frame: after 6 months
after 6 months
Assessment of metabolic effect on a 3-point scale
Time Frame: after 6 months
after 6 months
Change from Baseline in laboratory parameters
Time Frame: Baseline, after 6 months
Metabolic parameters - Triglyceride, total cholesterol, blood glucose, insulin, HOMA-Index, HbA1c
Baseline, after 6 months
Assessment of tolerability by investigator on a 5-point scale
Time Frame: after 6 months
after 6 months

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, 2006

Primary Completion (Actual)

October 1, 2006

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

  • 502.506

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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