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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00863980
Recruitment Status : Terminated (Principle investigator resigned in 2013)
First Posted : March 18, 2009
Last Update Posted : September 3, 2015
Sponsor:
Information provided by (Responsible Party):
Hiroyuki Yamada, Kyoto Prefectural University of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Angina Pectoris Myocardial Ischemia Acute Coronary Syndrome Hypertension Drug: Micardis (Telmisartan) Drug: Blopress (Candesartan) Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : April 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


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 Name: Blopless Tablets




Primary Outcome Measures :
  1. New or recurrent acute myocardial infarction and angina pectoris [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus [ Time Frame: 3 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863980


Locations
Show Show 32 study locations
Sponsors and Collaborators
Kyoto Prefectural University of Medicine
Investigators
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Study Chair: Hiroaki Matsubara, MD, PhD Kyoto Prefectural University of Medicine
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Responsible Party: Hiroyuki Yamada, Department of Cardiovascular Medicine, Kyoto Prefectural University of Medicine
ClinicalTrials.gov Identifier: NCT00863980    
Other Study ID Numbers: C-486
UMIN000001762
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: September 2015
Keywords provided by Hiroyuki Yamada, Kyoto Prefectural University of Medicine:
angiotensin
receptor
vulnerable plaque
coronary artery
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Myocardial Ischemia
Angina Pectoris
Infarction
Ischemia
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis
Heart Diseases
Chest Pain
Pain
Neurologic Manifestations
Telmisartan
Candesartan
Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action