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

Hypertension Clinical Trial

— KCPS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00863980
• Other study ID #: C-486
• Secondary ID: UMIN000001762
• Status: Terminated
• Phase: N/A
• First received: March 17, 2009
• Last updated: September 1, 2015
• Start date: April 2009
• Est. completion date: July 2013

Study information

• Verified date: September 2015
• Source: Kyoto Prefectural University of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1500
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Angina Pectoris
• Coronary Artery Disease
• Hypertension
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Drug:
• Micardis (Telmisartan)
40-80 mg/day oral administration
• Blopress (Candesartan)
8-12 mg/day oral administration

Locations

Country	Name	City	State
Japan	Akashi Municipal Hospital	Kobe
Japan	Shakaihoken Kobe Central Hospital	Kobe
Japan	Aijyukai Dohjin Hospital	Kyoto
Japan	Aiseikai Yamashina Hospital	Kyoto
Japan	Ayabe City Hospital	Kyoto
Japan	Fukuchiyama City Hospital	Kyoto
Japan	Gakkentoshi Hospital	Kyoto
Japan	Kouseikai Takeda Hospital	Kyoto
Japan	Kumihama Hospital	Kyoto
Japan	Kyoto City Hospital	Kyoto
Japan	Kyoto First Red Cross Hospital	Kyoto
Japan	Kyoto Kojyo Hokenkai	Kyoto
Japan	Kyoto Prefectural University of Medicine	Kyoto
Japan	Kyoto Prefectural Yosanoumi Hospital	Kyoto
Japan	Kyoto Second Red Cross Hospital	Kyoto
Japan	Kyoto Yawata Hospital	Kyoto
Japan	Maizuru Kyosai Hospital	Kyoto
Japan	Maizuru Red Cross Hospital	Kyoto
Japan	National Hospital Organization Maizuru Medical Center	Kyoto
Japan	Public Nantan Hospital	Kyoto
Japan	Public Yamasiro Hospital	Kyoto
Japan	Rakusai Simizu Hospital	Kyoto
Japan	Saiseikai Kyoto Hospital	Kyoto
Japan	Sakurakai Takahashi Hospital	Kyoto
Japan	Seizinkai Simizu Hospital	Kyoto
Japan	Social Insurance Kyoto Hospital	Kyoto
Japan	Tanabe Central Hospital	Kyoto
Japan	Uji Hospital	Kyoto
Japan	Matsushita Memorial Hospital	Osaka
Japan	Yuuseikai Midorigaoka Hospital	Osaka
Japan	Omihachiman Community Medical Center	Shiga
Japan	Saiseikai Shiga Hospital	Shiga

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto Prefectural University of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New or recurrent acute myocardial infarction and angina pectoris		3 years	Yes
Secondary	All causes of mortality, cardiovascular death, new or recurrent stroke or peripheral artery diseases, new occurrence of diabetes mellitus		3 years	Yes