Effects of Telmisartan on Ischemic Cardiovascular Events... | NCT00863980

ID	Type	Description	Link
UMIN000001762

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Principle investigator resigned in 2013

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Mar 17, 2009

First Submission Date that Met QC Criteria

Mar 17, 2009

First Posted Date

Mar 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2015

Last Update Posted Date

Sep 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Telmisartan	Experimental	Treatment with Telmisartan	Drug: Micardis (Telmisartan)
Candesartan	Active Comparator	Treatment with Candesartan	Drug: Blopress (Candesartan)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Micardis (Telmisartan)	Drug	40-80 mg/day oral administration	Telmisartan

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

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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

Exclusion Criteria:

The exclusion criteria are set as follows:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Shakaihoken Kobe Central Hospital		Kobe	Kobe	651-1145	Japan
Akashi Municipal Hospital

ID	Term
D000787	Angina Pectoris
D017202	Myocardial Ischemia
D054058	Acute Coronary Syndrome
D006973	Hypertension

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D002637	Chest Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000077333	Telmisartan
C077793	candesartan cilexetil
C081643	candesartan

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds