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

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan

• Registration Number: NCT00659581
• Lead Sponsor: Boehringer Ingelheim

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 available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2008-04-11
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-16
• Primary Completion: 2010-06
• Results First Submitted: 2011-12-16
• Results First Submitted QC: 2012-02-15
• Results First Posted: 2012-03-20
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21471

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with hypertension	Telmisartan	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events	3 years after initiation of treatment

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Systolic Blood Pressure at 12 Months	initiation and 12 months
Change From Baseline in Systolic Blood Pressure at 36 Months	initiation and 36 months
Change From Baseline in Diastolic Blood Pressure at 36 Months	initiation and 36 months
Change From Baseline in Diastolic Blood Pressure at 12 Months	initiation and 12 months
Change From Baseline in Diastolic Blood Pressure at 6 Months	initiation and 6 months
Change From Baseline in Systolic Blood Pressure at 24 Months	initiation and 24 months
Change From Baseline in Diastolic Blood Pressure at 24 Months	initiation and 24 months
Change From Baseline in Systolic Blood Pressure at 6 Months	initiation and 6 months