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
ClinicalTrials.gov Identifier:
NCT00659581
First received: April 11, 2008
Last updated: May 8, 2014
Last verified: March 2014
  Purpose

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

Condition Intervention
Hypertension
Drug: Telmisartan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Survey (Survey on Cerebrovascular and Cardiovascular Events Under Long-term Use) of Micardis Tablets (Telmisartan)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events [ Time Frame: 3 years after initiation of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21471
Study Start Date: April 2006
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with hypertension Drug: Telmisartan
Oral administration

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Japanese hypertension patients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659581

Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00659581     History of Changes
Other Study ID Numbers: 502.511
Study First Received: April 11, 2008
Results First Received: December 16, 2011
Last Updated: May 8, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014