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Completed

NCT Number: NCT00659581

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 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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telmisartan

Drug

Oral administration

Primary outcomes

  1. Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events

    Time frame: 3 years after initiation of treatment

Secondary outcomes

  1. Change From Baseline in Systolic Blood Pressure at 6 Months

    Time frame: initiation and 6 months

  2. Change From Baseline in Diastolic Blood Pressure at 6 Months

    Time frame: initiation and 6 months

  3. Change From Baseline in Systolic Blood Pressure at 12 Months

    Time frame: initiation and 12 months

  4. Change From Baseline in Diastolic Blood Pressure at 12 Months

    Time frame: initiation and 12 months

  5. Change From Baseline in Systolic Blood Pressure at 24 Months

    Time frame: initiation and 24 months

  6. Change From Baseline in Diastolic Blood Pressure at 24 Months

    Time frame: initiation and 24 months

  7. Change From Baseline in Systolic Blood Pressure at 36 Months

    Time frame: initiation and 36 months

  8. Change From Baseline in Diastolic Blood Pressure at 36 Months

    Time frame: initiation and 36 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Special Survey (Survey on Cerebrovascular and Cardiovascular Events Under Long-term Use) of Micardis Tablets (Telmisartan)

Important dates

Study start
2006
Primary completion
2010
First posted
Apr 16, 2008
Registry last updated
Aug 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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