Investigating the Effect of Telmisartan (Micardis®) on the Average 24h Blood Pressure of Therapy-naive and Therapy-experienced Patients
February 28, 2014 updated by: Boehringer Ingelheim
24h BP Under Micardis in Daily Practice
Practical experience report (PER) investigating the effect of Micardis® on the average 24h blood pressure of therapy-naive and therapy-experienced patients
Study Overview
Study Type
Observational
Enrollment (Actual)
670
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
18 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
hypertensive patients
Description
Inclusion criteria:
- Patients who have recently been diagnosed with hypertension
- Patients whose current blood pressure treatment are inadequate and needs to be revised are suitable for inclusion.
Exclusion criteria:
None (according to investigator)
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
arterial hypertension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy (Change of Systolic Blood Pressure)
Time Frame: baseline to 8 weeks
|
Change from baseline in 24h systolic blood pressure (BP) at week 8
|
baseline to 8 weeks
|
|
Efficacy (Change of Diastolic Blood Pressure)
Time Frame: baseline to 8 weeks
|
Change from baseline in 24h diastolic blood pressure (BP) at week 8
|
baseline to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
April 9, 2009
First Submitted That Met QC Criteria
April 9, 2009
First Posted (Estimate)
April 10, 2009
Study Record Updates
Last Update Posted (Estimate)
March 28, 2014
Last Update Submitted That Met QC Criteria
February 28, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 502.582
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.