Effectiveness of MICARDIS® (Telmisartan) on Blood Pressure Control and Quality of Live in Patients With Essential Hypertension (MicCAT)

September 16, 2014 updated by: Boehringer Ingelheim

An Open-label Evaluation of the Effectiveness of MICARDIS® (Telmisartan) on Blood Pressure Control and Quality of Life in Patients With Essential Hypertension The MICARDIS COMMUNITY ACCESS TRIAL (MicCAT)

Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to establish the effect on patient's quality of life scores.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3045

Phase

  • Phase 4

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

20 years to 93 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Stage I essential Hypertension (diastolic blood pressure 90-99 mmHg, and/or systolic blood pressure 140-159 mmHg)
  • Signed informed consent form

Exclusion Criteria:

- Females of childbearing potential

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telmisartan low dose
Drug: Low dose of telmisartan
Experimental: Telmisartan high dose
Drug: High dose of telmisartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in diastolic blood pressure
Time Frame: Pre-dose, up to 6 weeks after start of treatment
Pre-dose, up to 6 weeks after start of treatment
Change in systolic blood pressure
Time Frame: Pre-dose, up to 6 weeks after start of treatment
Pre-dose, up to 6 weeks after start of treatment
Changes from baseline in the quality of life (QOL) scores by patient self-assessment
Time Frame: Pre-dose, 6 weeks after start of treatment
Pre-dose, 6 weeks after start of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of blood pressure control rate
Time Frame: Up to 6 weeks after start of treatment
Up to 6 weeks after start of treatment
Assessment of systolic blood pressure response rate
Time Frame: Up to 6 weeks after start of treatment
Up to 6 weeks after start of treatment
Assessment of diastolic blood pressure response rate
Time Frame: Up to 6 weeks after start of treatment
Up to 6 weeks after start of treatment
Change from baseline in pulse pressure
Time Frame: Pre-dose, up to 6 weeks after start of treatment
Pre-dose, up to 6 weeks after start of treatment
Number of patients with adverse events
Time Frame: Up to 6 weeks
Up to 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

September 1, 1999

Primary Completion (Actual)

November 1, 2000

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

  • 502.461

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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