NCT00863980

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

32 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 3, 2015

Status Verified

September 1, 2015

Enrollment Period

4.3 years

First QC Date

March 17, 2009

Last Update Submit

September 1, 2015

Conditions

Acute Myocardial InfarctionAngina PectorisMyocardial IschemiaAcute Coronary SyndromeHypertension

Keywords

angiotensinreceptorvulnerable plaquecoronary artery

Outcome Measures

Primary Outcomes (1)

  • New or recurrent acute myocardial infarction and angina pectoris

    3 years

Secondary Outcomes (1)

  • All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus

    3 years

Study Arms (2)

Telmisartan

EXPERIMENTAL

Treatment with Telmisartan

Drug: Micardis (Telmisartan)

Candesartan

ACTIVE COMPARATOR

Treatment with Candesartan

Drug: Blopress (Candesartan)

Interventions

Micardis (Telmisartan)DRUG

40-80 mg/day oral administration

Also known as: 21600AMZ00541000, Micardis Tablets 40mg
Telmisartan
Blopress (Candesartan)DRUG

8-12 mg/day oral administration

Also known as: Blopless Tablets
Candesartan

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Peripheral arterial disease undergoing percutaneous transluminal angioplasty (PTA) or peripheral artery bypass grafting at least 6 months before enrollment
  • Symptomatic cerebral infarction or cerebral hemorrhage at least 6 months before enrollment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Shakaihoken Kobe Central Hospital

Kobe, Kobe, 651-1145, Japan

Location

Akashi Municipal Hospital

Kobe, Kobe, 673-8501, Japan

Location

Kouseikai Takeda Hospital

Kyoto, Kyoto, 600-8558, Japan

Location

Aijyukai Dohjin Hospital

Kyoto, Kyoto, 602-0917, Japan

Location

Kyoto Second Red Cross Hospital

Kyoto, Kyoto, 602-8026, Japan

Location

Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 602-8566, Japan

Location

Social Insurance Kyoto Hospital

Kyoto, Kyoto, 603-8151, Japan

Location

Kyoto Kojyo Hokenkai

Kyoto, Kyoto, 604-8472, Japan

Location

Kyoto City Hospital

Kyoto, Kyoto, 604-8845, Japan

Location

Kyoto First Red Cross Hospital

Kyoto, Kyoto, 605-0981, Japan

Location

Aiseikai Yamashina Hospital

Kyoto, Kyoto, 607-8086, Japan

Location

Tanabe Central Hospital

Kyoto, Kyoto, 610-0334, Japan

Location

Rakusai Simizu Hospital

Kyoto, Kyoto, 610-1106, Japan

Location

Uji Hospital

Kyoto, Kyoto, 611-0011, Japan

Location

Kyoto Yawata Hospital

Kyoto, Kyoto, 614-8114, Japan

Location

Seizinkai Simizu Hospital

Kyoto, Kyoto, 615-8237, Japan

Location

Saiseikai Kyoto Hospital

Kyoto, Kyoto, 617-0814, Japan

Location

Public Yamasiro Hospital

Kyoto, Kyoto, 619-0214, Japan

Location

Gakkentoshi Hospital

Kyoto, Kyoto, 619-0238, Japan

Location

Fukuchiyama City Hospital

Kyoto, Kyoto, 620-8505, Japan

Location

Ayabe City Hospital

Kyoto, Kyoto, 623-0011, Japan

Location

Maizuru Red Cross Hospital

Kyoto, Kyoto, 624-0906, Japan

Location

National Hospital Organization Maizuru Medical Center

Kyoto, Kyoto, 625-8502, Japan

Location

Maizuru Kyosai Hospital

Kyoto, Kyoto, 625-8585, Japan

Location

Public Nantan Hospital

Kyoto, Kyoto, 629-0197, Japan

Location

Kyoto Prefectural Yosanoumi Hospital

Kyoto, Kyoto, 629-2261, Japan

Location

Kumihama Hospital

Kyoto, Kyoto, 629-3403, Japan

Location

Sakurakai Takahashi Hospital

Kyoto, Kyoto, 654-0026, Japan

Location

Yuuseikai Midorigaoka Hospital

Osaka, Osaka, 569-1121, Japan

Location

Matsushita Memorial Hospital

Osaka, Osaka, 570-8540, Japan

Location

Saiseikai Shiga Hospital

Shiga, Shiga, 520-3046, Japan

Location

Omihachiman Community Medical Center

Shiga, Shiga, 523-0892, Japan

Location

MeSH Terms

Conditions

Angina PectorisMyocardial IschemiaAcute Coronary SyndromeHypertension

Interventions

Telmisartancandesartan cilexetilcandesartan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Hiroaki Matsubara, MD, PhD

    Kyoto Prefectural University of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Cardiovascular Medicine

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 18, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 3, 2015

Record last verified: 2015-09

Locations

JP(32)