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

NCT00659581 | Completed Results

• 1 other identifier: 502.511
• Study Type: observational
• Target: 21,471
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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

  3 years after initiation of treatment

Secondary Outcomes (8)

• Change From Baseline in Systolic Blood Pressure at 6 Months

  initiation and 6 months

• Change From Baseline in Diastolic Blood Pressure at 6 Months

  initiation and 6 months

• Change From Baseline in Systolic Blood Pressure at 12 Months

  initiation and 12 months

• Change From Baseline in Diastolic Blood Pressure at 12 Months

  initiation and 12 months

• Change From Baseline in Systolic Blood Pressure at 24 Months

  initiation and 24 months

Study Arms (1)

Patients with hypertension

Drug: Telmisartan

Interventions

Telmisartan DRUG

Oral administration

Patients with hypertension

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Japanese hypertension patients

You may qualify if:

• Hypertension patients unadministered Micardis.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

This study is prospective observational study with no limitation of other antihypertensive treatment in compliance with Japanese Pharmaceutical Affairs Law (JPAL) and Good Post-marketing Study Practice (GPSP).

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 16, 2008
• Study Start: April 1, 2006
• Primary Completion: June 1, 2010
• Last Updated: August 25, 2016
• Results First Posted: March 20, 2012

Record last verified: 2016-07