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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00659581

First received: April 11, 2008

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 11, 2008

Last Updated Date

May 18, 2012

Start Date ^ICMJE

April 2006

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events [ Time Frame: 3 years after initiation of treatment ] [ Designated as safety issue: No ]
Change From Baseline in Systolic Blood Pressure at 6 Months [ Time Frame: initiation and 6 months ] [ Designated as safety issue: No ]
Change From Baseline in Diastolic Blood Pressure at 6 Months [ Time Frame: initiation and 6 months ] [ Designated as safety issue: No ]
Change From Baseline in Systolic Blood Pressure at 12 Months [ Time Frame: initiation and 12 months ] [ Designated as safety issue: No ]
Change From Baseline in Diastolic Blood Pressure at 12 Months [ Time Frame: initiation and 12 months ] [ Designated as safety issue: No ]
Change From Baseline in Systolic Blood Pressure at 24 Months [ Time Frame: initiation and 24 months ] [ Designated as safety issue: No ]
Change From Baseline in Diastolic Blood Pressure at 24 Months [ Time Frame: initiation and 24 months ] [ Designated as safety issue: No ]
Change From Baseline in Systolic Blood Pressure at 36 Months [ Time Frame: initiation and 36 months ] [ Designated as safety issue: No ]
Change From Baseline in Diastolic Blood Pressure at 36 Months [ Time Frame: initiation and 36 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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 ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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:

Adverse events and adverse drug reactions under long-term use
Blood pressure measurements during the survey period
Determination of the incidence of cerebrovascular and cardiovascular events under use of this drug in routine clinical settings
Patient's lifestyle and background factors that are considered to affect the occurrence of cerebrovascular and cardiovascular events

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Telmisartan

Oral administration

Study Group/Cohort (s)

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 ^ICMJE

Completed

Enrollment ^ICMJE

21471

Completion Date

Not Provided

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Hypertension patients unadministered Micardis.

Exclusion criteria:

Patients with a history of hypersensitivity to any ingredient of this product.
Pregnant woman or possibly pregnant woman
Patients with extremely poor bile secretion or patients with serious hepatic disorder

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00659581

Other Study ID Numbers ^ICMJE

502.511

Has Data Monitoring Committee

Not Provided

Responsible Party

Boehringer Ingelheim Pharmaceuticals

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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