Micardis®. Observational Study in Patients With Essential Hypertension
July 24, 2014 updated by: Boehringer Ingelheim
Micardis®. Observational Study
This study is designed to supplement, under conditions of usual clinical practice, the data on the efficacy and safety of Micardis® collected during the clinical studies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
4532
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Outpatients over 18 years of age suffering essential hypertension, treated by general practitioners and/or specialists
Description
Inclusion Criteria:
- Patients of either sex over the age of 18 years suffering from essential hypertension requiring treatment according to the physician
Exclusion Criteria:
- Hypersensitivity to the active component or to any of the excipients
- Pregnancy and lactation
- Biliary obstructive disorders
- Severe hepatic impairment
- Severe renal impairment
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 |
|---|---|
|
Outpatients with essential hypertension
|
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in systolic and diastolic blood pressure
Time Frame: Baseline, 4 weeks and 3 months after start of treatment
|
Baseline, 4 weeks and 3 months after start of treatment
|
|
Percentage of patients with dose titration to 80 mg
Time Frame: 4 weeks and 3 months after start of treatment
|
4 weeks and 3 months after start of treatment
|
|
Number of patients with adverse events
Time Frame: Up to 3 months after start of treatment
|
Up to 3 months after start of treatment
|
|
Global evaluation of treatment compliance by investigator, a 6-point rating scale
Time Frame: 4 weeks and 3 months after start of treatment
|
4 weeks and 3 months after start of treatment
|
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
December 1, 1999
Primary Completion (Actual)
October 1, 2000
Study Registration Dates
First Submitted
July 24, 2014
First Submitted That Met QC Criteria
July 24, 2014
First Posted (Estimate)
July 25, 2014
Study Record Updates
Last Update Posted (Estimate)
July 25, 2014
Last Update Submitted That Met QC Criteria
July 24, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 502.361
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.