J-TARGET,Japanese Telmisartan Study for Antihypertensive Good Effect in Long Term Observation
The primary objective of this post marketing survey is to prospectively investigate patients with hypertension treated with Micardis Tablets (hereinafter "this drug") in routine clinical settings for 3 years in order to determine the following: 1. Adverse events and adverse drug reactions under long-term use 2. Blood pressure measurements during the survey period 3. Determination of the incidence...
Brief Summary
Official Title: “Special Survey (Survey on Cerebrovascular and Cardiovascular Events Under Long-term Use) of Micardis Tablets (Telmisartan)”
The primary objective of this post marketing survey is to prospectively investigate patients with hypertension treated with Micardis Tablets (hereinafter "this drug") in routine clinical settings for 3 years in order to determine the following:
1. Adverse events and adverse drug reactions under long-term use
2. Blood pressure measurements during the survey period
3. Determination of the incidence of cerebrovascular and cardiovascular events under use of this drug in routine clinical settings
4. Patient's lifestyle and background factors that are considered to affect the occurrence of cerebrovascular and cardiovascular events
- Study Type: Observational
- Study Design: Observational Model: Case-Only, Time Perspective: Prospective
- Study Primary Completion Date: June 2010
Arms, Groups and Cohorts in this Clinical Trial
- : Patients with hypertension
- Men and women with hypertension
Outcome Measures for this Clinical Trial
Primary Measures
- Adverse events
- Time Frame: 3 years
Safety Issue?: No
- Time Frame: 3 years
- Adverse drug reactions
- Time Frame: 3 years
Safety Issue?: No
- Time Frame: 3 years
- The incidence of cerebrovascular and cardiovascular events
- Time Frame: 3 years
Safety Issue?: No
- Time Frame: 3 years
Secondary Measures
- Blood pressure
- Time Frame: 3 years
Safety Issue?: No
- Time Frame: 3 years
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Hypertension patients unadministered Micardis.
Exclusion Criteria:
- 1. Patients with a history of hypersensitivity to any ingredient of this product.
- 2. Pregnant woman or possibly pregnant woman
- 3. Patients with extremely poor bile secretion or patients with serious hepatic disorder
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Boehringer Ingelheim Pharmaceuticals Industry
Overall Clinical Trial Officials and Contacts
Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00659581
Study ID Number: 502.511
ClinicalTrials.gov Identifier: NCT00659581
Health Authority: Japan: Ministry of Health, Labor and Welfare
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00659581
