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...
Date First Received: April 11, 2008
Last Updated: October 22, 2008
Verified by: Boehringer Ingelheim Pharmaceuticals, October 2008
Clinical Trial Phase: Phase 4 | Start Date:
Overall Status: Active, not recruiting
Estimated Enrollment: 15000
Brief Summary
Official Title: “Special Survey (Survey on Cerebrovascular and Cardiovascular Events Under Long-Term Use) of Micardis Tablets (Telmisartan)”
Condition Keyword(s):
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: N/A
Outcome Measures for this Clinical Trial
Primary Measures
- Safety and Efficacy Safety: Adverse events, Adverse drug reactions Efficacy: Blood pressure
Secondary Measures
- The incidence of cerebrovascular and cardiovascular events Patient's lifestyle and background factors that are considered to affect the occurrence of cerebrovascular and cardiovascular events
Criteria for Participation in this Clinical Trial
- Hypertension patients unadministered Micardis.
- 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 Sponsor Information
Lead Sponsor: Boehringer Ingelheim Pharmaceuticals
Overall Clinical Trial Officials and Contacts
Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
