Effects of Telmisartan on Ischemic Cardiovascular Events in High-risk Hypertensive Patients

NCT ID: NCT00863980

Last Updated: 2015-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-07-31

Brief Summary

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This study is aimed to investigate whether treatment with Telmisartan is more effective than Candesartan in reducing the ischemic cardiovascular events in high-risk patients with cardiovascular disease.

Detailed Description

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This study is aimed to investigate whether treatment with Telmisartan is more effective than Candesartan in reducing the ischemic cardiovascular events in high-risk patients with cardiovascular disease.

Study design: PROBE(Prospective, Randomized, Open-labeled Blind Endpoints)

Conditions

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Acute Myocardial Infarction Angina Pectoris Myocardial Ischemia Acute Coronary Syndrome Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Telmisartan

Treatment with Telmisartan

Group Type EXPERIMENTAL

Micardis (Telmisartan)

Intervention Type DRUG

40-80 mg/day oral administration

Candesartan

Treatment with Candesartan

Group Type ACTIVE_COMPARATOR

Blopress (Candesartan)

Intervention Type DRUG

8-12 mg/day oral administration

Interventions

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Micardis (Telmisartan)

40-80 mg/day oral administration

Intervention Type DRUG

Blopress (Candesartan)

8-12 mg/day oral administration

Intervention Type DRUG

Other Intervention Names

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21600AMZ00541000 Micardis Tablets 40mg Blopless Tablets

Eligibility Criteria

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Inclusion Criteria

1. Coronary artery disease documented by at least one of the following:

* Myocardial infarction at least 12 months before enrollment and not planned for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
* Angina pectoris or asymptomatic myocardial ischemia undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at least 12 months before enrollment and not planned for further percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
2. Peripheral arterial disease undergoing percutaneous transluminal angioplasty (PTA) or peripheral artery bypass grafting at least 6 months before enrollment
3. Symptomatic cerebral infarction or cerebral hemorrhage at least 6 months before enrollment

Exclusion Criteria

1. History of worsening of heart failure within the preceding 6 months
2. Planned elective percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the anteceding 3 months
3. History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the preceding 12 months
4. History of percutaneous hind limb angioplasty (PTA) or bypass grafting within the preceding 6 months
5. History of cerebral infarction, cerebral hemorrhage within the past 6 months
6. Congenital heart disease
7. Uncontrolled hypertension on treatment (eg, BP\>180/110 mmHg)
8. Pregnant women or women of childbearing potential
9. Hepatic dysfunction (AST or ALT \>100IU/L)
10. Renal impairment (serum creatinine level \>2.0 mg per 100 ml)
11. Known hypersensitivity or intolerance to ARB
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyoto Prefectural University of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hiroyuki Yamada

Department of Cardiovascular Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hiroaki Matsubara, MD, PhD

Role: STUDY_CHAIR

Kyoto Prefectural University of Medicine

Locations

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Shakaihoken Kobe Central Hospital

Kobe, Kobe, Japan

Site Status

Akashi Municipal Hospital

Kobe, Kobe, Japan

Site Status

Kouseikai Takeda Hospital

Kyoto, Kyoto, Japan

Site Status

Aijyukai Dohjin Hospital

Kyoto, Kyoto, Japan

Site Status

Kyoto Second Red Cross Hospital

Kyoto, Kyoto, Japan

Site Status

Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Site Status

Social Insurance Kyoto Hospital

Kyoto, Kyoto, Japan

Site Status

Kyoto Kojyo Hokenkai

Kyoto, Kyoto, Japan

Site Status

Kyoto City Hospital

Kyoto, Kyoto, Japan

Site Status

Kyoto First Red Cross Hospital

Kyoto, Kyoto, Japan

Site Status

Aiseikai Yamashina Hospital

Kyoto, Kyoto, Japan

Site Status

Tanabe Central Hospital

Kyoto, Kyoto, Japan

Site Status

Rakusai Simizu Hospital

Kyoto, Kyoto, Japan

Site Status

Uji Hospital

Kyoto, Kyoto, Japan

Site Status

Kyoto Yawata Hospital

Kyoto, Kyoto, Japan

Site Status

Seizinkai Simizu Hospital

Kyoto, Kyoto, Japan

Site Status

Saiseikai Kyoto Hospital

Kyoto, Kyoto, Japan

Site Status

Public Yamasiro Hospital

Kyoto, Kyoto, Japan

Site Status

Gakkentoshi Hospital

Kyoto, Kyoto, Japan

Site Status

Fukuchiyama City Hospital

Kyoto, Kyoto, Japan

Site Status

Ayabe City Hospital

Kyoto, Kyoto, Japan

Site Status

Maizuru Red Cross Hospital

Kyoto, Kyoto, Japan

Site Status

National Hospital Organization Maizuru Medical Center

Kyoto, Kyoto, Japan

Site Status

Maizuru Kyosai Hospital

Kyoto, Kyoto, Japan

Site Status

Public Nantan Hospital

Kyoto, Kyoto, Japan

Site Status

Kyoto Prefectural Yosanoumi Hospital

Kyoto, Kyoto, Japan

Site Status

Kumihama Hospital

Kyoto, Kyoto, Japan

Site Status

Sakurakai Takahashi Hospital

Kyoto, Kyoto, Japan

Site Status

Yuuseikai Midorigaoka Hospital

Osaka, Osaka, Japan

Site Status

Matsushita Memorial Hospital

Osaka, Osaka, Japan

Site Status

Saiseikai Shiga Hospital

Shiga, Shiga, Japan

Site Status

Omihachiman Community Medical Center

Shiga, Shiga, Japan

Site Status

Countries

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Japan

Other Identifiers

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UMIN000001762

Identifier Type: -

Identifier Source: secondary_id

C-486

Identifier Type: -

Identifier Source: org_study_id

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