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A Trial of Telmisartan Prevention of Cardiovascular Disease

NCT01075698 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1228

Last updated 2016-09-07

No results posted yet for this study

Summary

The present research is conducted as a randomized, parallel-group, controlled, open study (using the PROBE method) to primarily verify the effects on various biomarkers in high-risk hypertensive patients treated with ARB (telmisartan, ARB group) as compared with those in patients receiving ordinary therapy (non-ARB group (ordinary therapy group)). In addition, onset of cardiovascular events and levels of markers that are associated with cardiovascular events are observed over time to examine the significance of each marker. The biomarkers will be obtained at the start of the study (at registration), after 6, 12, 24 and 36 months from the start of the study.

Conditions

Interventions

DRUG

Non-ARB (standard therapy)

Blood pressure lowering therapy except ARB

DRUG

ARB (Telmisartan)

Telmisartan 20-80 mg/day

Sponsors & Collaborators

  • Japan Foundation for Aging and Health

    collaborator OTHER

  • Kumamoto University

    lead OTHER

Principal Investigators

  • Hisao Ogawa, Prof., MD, PhD · Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

  • Shokei Kim-Mitsuyama, Prof., MD, PhD · Department of Pharmacology and Molecular Therapeutics, Graduate School of Medical Sciences, Kumamoto University

  • Koichi Node, Prof, MD, PhD · Department of Cardiovascular and Renal Medicine, Saga University Faculty of Medicine

  • Hirofumi Soejima, MD, PhD · Health Care Center / Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

  • Osamu Yasuda, MD, PhD · Department of Cardiovascular Clinical and Translational Research, Kumamoto University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2015-02-28
Completion
2016-03-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01075698 on ClinicalTrials.gov