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

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Low dose of telmisartan
High dose of telmisartan
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

20 Years - 93 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Telmisartan low dose

    Telmisartan high dose

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in diastolic blood pressure
    Change in systolic blood pressure
    Changes from baseline in the quality of life (QOL) scores by patient self-assessment

    Secondary Outcome Measures

    Assessment of blood pressure control rate
    Assessment of systolic blood pressure response rate
    Assessment of diastolic blood pressure response rate
    Change from baseline in pulse pressure
    Number of patients with adverse events

    Full Information

    First Posted
    September 16, 2014
    Last Updated
    September 16, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02242370
    Brief Title
    Effectiveness of MICARDIS® (Telmisartan) on Blood Pressure Control and Quality of Live in Patients With Essential Hypertension
    Acronym
    MicCAT
    Official Title
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1999 (undefined)
    Primary Completion Date
    November 2000 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    3045 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Telmisartan low dose
    Arm Type
    Experimental
    Arm Title
    Telmisartan high dose
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Low dose of telmisartan
    Intervention Type
    Drug
    Intervention Name(s)
    High dose of telmisartan
    Primary Outcome Measure Information:
    Title
    Change in diastolic blood pressure
    Time Frame
    Pre-dose, up to 6 weeks after start of treatment
    Title
    Change in systolic blood pressure
    Time Frame
    Pre-dose, up to 6 weeks after start of treatment
    Title
    Changes from baseline in the quality of life (QOL) scores by patient self-assessment
    Time Frame
    Pre-dose, 6 weeks after start of treatment
    Secondary Outcome Measure Information:
    Title
    Assessment of blood pressure control rate
    Time Frame
    Up to 6 weeks after start of treatment
    Title
    Assessment of systolic blood pressure response rate
    Time Frame
    Up to 6 weeks after start of treatment
    Title
    Assessment of diastolic blood pressure response rate
    Time Frame
    Up to 6 weeks after start of treatment
    Title
    Change from baseline in pulse pressure
    Time Frame
    Pre-dose, up to 6 weeks after start of treatment
    Title
    Number of patients with adverse events
    Time Frame
    Up to 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    93 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com
    Description
    Related Info

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

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