Back to resultsEffectiveness 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
About this trial
This is an interventional treatment trial for Hypertension
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
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
NCT ID
NCT02242370
First Posted
September 16, 2014
Last Updated
September 16, 2014
Sponsor
Boehringer Ingelheim
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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