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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

Tracking Information
First Submitted Date  ICMJE March 17, 2009
First Posted Date  ICMJE March 18, 2009
Last Update Posted Date September 3, 2015
Study Start Date  ICMJE April 2009
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2011)
New or recurrent acute myocardial infarction and angina pectoris [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
New or recurrent acute myocardial infarction, angina pectoris, and asymptomatic myocardial ischemia [ Time Frame: 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Telmisartan on Ischemic Cardiovascular Events in High-risk Hypertensive Patients
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Acute Myocardial Infarction
  • Angina Pectoris
  • Myocardial Ischemia
  • Acute Coronary Syndrome
  • Hypertension
Intervention  ICMJE
  • Drug: Micardis (Telmisartan)
    40-80 mg/day oral administration
    Other Names:
    • 21600AMZ00541000
    • Micardis Tablets 40mg
  • Drug: Blopress (Candesartan)
    8-12 mg/day oral administration
    Other Name: Blopless Tablets
Study Arms  ICMJE
  • Experimental: Telmisartan
    Treatment with Telmisartan
    Intervention: Drug: Micardis (Telmisartan)
  • Active Comparator: Candesartan
    Treatment with Candesartan
    Intervention: Drug: Blopress (Candesartan)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 17, 2009)
1500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00863980
Other Study ID Numbers  ICMJE C-486
UMIN000001762
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hiroyuki Yamada, Kyoto Prefectural University of Medicine
Study Sponsor  ICMJE Kyoto Prefectural University of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hiroaki Matsubara, MD, PhD Kyoto Prefectural University of Medicine
PRS Account Kyoto Prefectural University of Medicine
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP