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Investigating the Effect of Telmisartan (Micardis®) on the Average 24h Blood Pressure of Therapy-naive and Therapy-experienced Patients

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ClinicalTrials.gov Identifier: NCT00879411
Recruitment Status : Completed
First Posted : April 10, 2009
Results First Posted : May 15, 2012
Last Update Posted : March 28, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
Practical experience report (PER) investigating the effect of Micardis® on the average 24h blood pressure of therapy-naive and therapy-experienced patients

Condition or disease Intervention/treatment
Hypertension Drug: Micardis

Study Design

Study Type : Observational
Actual Enrollment : 670 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 24h BP Under Micardis in Daily Practice
Study Start Date : April 2009
Primary Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
arterial hypertension Drug: Micardis

Outcome Measures

Primary Outcome Measures :
  1. Efficacy (Change of Systolic Blood Pressure) [ Time Frame: baseline to 8 weeks ]
    Change from baseline in 24h systolic blood pressure (BP) at week 8

  2. Efficacy (Change of Diastolic Blood Pressure) [ Time Frame: baseline to 8 weeks ]
    Change from baseline in 24h diastolic blood pressure (BP) at week 8

Secondary Outcome Measures :
  1. Overall Tolerability Scale [ Time Frame: 8 weeks ]
    Safety and tolerability of Micardis® in the treatment of patients with hypertension over 8 weeks, using 10 point Likert scale with worst score=1, best score=10

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hypertensive patients

Inclusion criteria:

  1. Patients who have recently been diagnosed with hypertension
  2. Patients whose current blood pressure treatment are inadequate and needs to be revised are suitable for inclusion.

Exclusion criteria:

None (according to investigator)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879411

Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00879411     History of Changes
Other Study ID Numbers: 502.582
First Posted: April 10, 2009    Key Record Dates
Results First Posted: May 15, 2012
Last Update Posted: March 28, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action