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J-TARGET,Japanese Telmisartan Study for Antihypertensive Good Effect in Long Term Observation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00659581
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : March 20, 2012
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date April 11, 2008
First Posted Date April 16, 2008
Results First Submitted Date December 16, 2011
Results First Posted Date March 20, 2012
Last Update Posted Date August 25, 2016
Study Start Date April 2006
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2014)
Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events [ Time Frame: 3 years after initiation of treatment ]
Original Primary Outcome Measures
 (submitted: April 15, 2008)
Safety and Efficacy Safety: Adverse events, Adverse drug reactions Efficacy: Blood pressure [ Time Frame: 3 years ]
Change History Complete list of historical versions of study NCT00659581 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 12, 2014)
  • Change From Baseline in Systolic Blood Pressure at 6 Months [ Time Frame: initiation and 6 months ]
  • Change From Baseline in Diastolic Blood Pressure at 6 Months [ Time Frame: initiation and 6 months ]
  • Change From Baseline in Systolic Blood Pressure at 12 Months [ Time Frame: initiation and 12 months ]
  • Change From Baseline in Diastolic Blood Pressure at 12 Months [ Time Frame: initiation and 12 months ]
  • Change From Baseline in Systolic Blood Pressure at 24 Months [ Time Frame: initiation and 24 months ]
  • Change From Baseline in Diastolic Blood Pressure at 24 Months [ Time Frame: initiation and 24 months ]
  • Change From Baseline in Systolic Blood Pressure at 36 Months [ Time Frame: initiation and 36 months ]
  • Change From Baseline in Diastolic Blood Pressure at 36 Months [ Time Frame: initiation and 36 months ]
Original Secondary Outcome Measures
 (submitted: April 15, 2008)
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 [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title J-TARGET,Japanese Telmisartan Study for Antihypertensive Good Effect in Long Term Observation
Official Title Special Survey (Survey on Cerebrovascular and Cardiovascular Events Under Long-term Use) of Micardis Tablets (Telmisartan)
Brief Summary

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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Japanese hypertension patients
Condition Hypertension
Intervention Drug: Telmisartan
Oral administration
Study Groups/Cohorts Patients with hypertension
Intervention: Drug: Telmisartan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 15, 2010)
21471
Original Enrollment
 (submitted: April 15, 2008)
15000
Study Completion Date Not Provided
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Japan
 
Administrative Information
NCT Number NCT00659581
Other Study ID Numbers 502.511
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Not Provided
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date July 2016