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

September 1, 2015 updated by: Hiroyuki Yamada, Kyoto Prefectural University of Medicine

Effects of Telmisartan Compared With Candesartan on Ischemic Cardiovascular Events in High-risk Hypertensive Patients: a Multi-center, Prospective, Randomized, Open-labeled, Blinded Endpoints Trial

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Actual)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kobe, Japan, 651-1145
        • Shakaihoken Kobe Central Hospital
      • Kobe, Japan, 673-8501
        • Akashi Municipal Hospital
      • Kyoto, Japan, 602-8566
        • Kyoto Prefectural University of Medicine
      • Kyoto, Japan, 600-8558
        • Kouseikai Takeda Hospital
      • Kyoto, Japan, 602-0917
        • Aijyukai Dohjin Hospital
      • Kyoto, Japan, 602-8026
        • Kyoto Second Red Cross Hospital
      • Kyoto, Japan, 603-8151
        • Social Insurance Kyoto Hospital
      • Kyoto, Japan, 604-8472
        • Kyoto Kojyo Hokenkai
      • Kyoto, Japan, 604-8845
        • Kyoto City Hospital
      • Kyoto, Japan, 605-0981
        • Kyoto First Red Cross Hospital
      • Kyoto, Japan, 607-8086
        • Aiseikai Yamashina Hospital
      • Kyoto, Japan, 610-0334
        • Tanabe Central Hospital
      • Kyoto, Japan, 610-1106
        • Rakusai Simizu Hospital
      • Kyoto, Japan, 611-0011
        • Uji Hospital
      • Kyoto, Japan, 614-8114
        • Kyoto Yawata Hospital
      • Kyoto, Japan, 615-8237
        • Seizinkai Simizu Hospital
      • Kyoto, Japan, 617-0814
        • Saiseikai Kyoto Hospital
      • Kyoto, Japan, 619-0214
        • Public Yamasiro Hospital
      • Kyoto, Japan, 619-0238
        • Gakkentoshi Hospital
      • Kyoto, Japan, 620-8505
        • Fukuchiyama City Hospital
      • Kyoto, Japan, 623-0011
        • Ayabe City Hospital
      • Kyoto, Japan, 624-0906
        • Maizuru Red Cross Hospital
      • Kyoto, Japan, 625-8502
        • National Hospital Organization Maizuru Medical Center
      • Kyoto, Japan, 625-8585
        • Maizuru Kyosai Hospital
      • Kyoto, Japan, 629-0197
        • Public Nantan Hospital
      • Kyoto, Japan, 629-2261
        • Kyoto Prefectural Yosanoumi Hospital
      • Kyoto, Japan, 629-3403
        • Kumihama Hospital
      • Kyoto, Japan, 654-0026
        • Sakurakai Takahashi Hospital
      • Osaka, Japan, 569-1121
        • Yuuseikai Midorigaoka Hospital
      • Osaka, Japan, 570-8540
        • Matsushita Memorial Hospital
      • Shiga, Japan, 520-3046
        • Saiseikai Shiga Hospital
      • Shiga, Japan, 523-0892
        • Omihachiman Community Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The inclusion criteria are set by at least one of the three following risk factors:

  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:

The exclusion criteria are set as follows:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telmisartan
Treatment with Telmisartan
Drug: Micardis (Telmisartan)
40-80 mg/day oral administration
Other Names:
  • 21600AMZ00541000
  • Micardis Tablets 40mg
Active Comparator: Candesartan
Treatment with Candesartan
Drug: Blopress (Candesartan)
8-12 mg/day oral administration
Other Names:
  • Blopless Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
New or recurrent acute myocardial infarction and angina pectoris
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto Prefectural University of Medicine

Investigators

  • Study Chair: Hiroaki Matsubara, MD, PhD, Kyoto Prefectural University of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (Estimate)

March 18, 2009

Study Record Updates

Last Update Posted (Estimate)

September 3, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-486
  • UMIN000001762

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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