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

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ClinicalTrials.gov Identifier: NCT02242370
Recruitment Status : Completed
First Posted : September 17, 2014
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Low dose of telmisartan Drug: High dose of telmisartan Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3045 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 1999
Actual Primary Completion Date : November 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Arm Intervention/treatment
Experimental: Telmisartan low dose Drug: Low dose of telmisartan
Experimental: Telmisartan high dose Drug: High dose of telmisartan



Primary Outcome Measures :
  1. Change in diastolic blood pressure [ Time Frame: Pre-dose, up to 6 weeks after start of treatment ]
  2. Change in systolic blood pressure [ Time Frame: Pre-dose, up to 6 weeks after start of treatment ]
  3. 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 Measures :
  1. Assessment of blood pressure control rate [ Time Frame: Up to 6 weeks after start of treatment ]
  2. Assessment of systolic blood pressure response rate [ Time Frame: Up to 6 weeks after start of treatment ]
  3. Assessment of diastolic blood pressure response rate [ Time Frame: Up to 6 weeks after start of treatment ]
  4. Change from baseline in pulse pressure [ Time Frame: Pre-dose, up to 6 weeks after start of treatment ]
  5. Number of patients with adverse events [ Time Frame: Up to 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 93 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02242370     History of Changes
Other Study ID Numbers: 502.461
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action