- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02242357
Study to Evaluate Efficacy and Tolerability of Micardis®/Micardis® Plus in Patients With Hypertension
September 16, 2014 updated by: Boehringer Ingelheim
Post-Marketing Surveillance Study Micardis® Plus
Study to evaluate efficacy and tolerability of Micardis®/Micardis® Plus under usual daily-practice prescribing conditions in hypertensive patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
14553
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 with hypertension
Description
Inclusion Criteria:
- Males and females for whom a medical antihypertensive therapy is indicated
- Age >= 18 years
Exclusion Criteria:
- Age < 18 years
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with hypertension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in morning blood pressure (office and self-measured)
Time Frame: up to 6 weeks
|
up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse drug reactions
Time Frame: up to 6 weeks
|
up to 6 weeks
|
Change in heart rate
Time Frame: up to 6 weeks
|
up to 6 weeks
|
Assessment of efficacy by investigator on a 5-point scale
Time Frame: at week 6
|
at week 6
|
Assessment of tolerability by investigator on 5-point scale
Time Frame: at week 6
|
at week 6
|
Change in rate of morning complaints
Time Frame: up to 6 weeks
|
up to 6 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
January 1, 2003
Primary Completion (Actual)
July 1, 2003
Study Registration Dates
First Submitted
September 16, 2014
First Submitted That Met QC Criteria
September 16, 2014
First Posted (Estimate)
September 17, 2014
Study Record Updates
Last Update Posted (Estimate)
September 17, 2014
Last Update Submitted That Met QC Criteria
September 16, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 502.427
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.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Addpharma Inc.Completed
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
Clinical Trials on Micardis®
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted