NCT01075698

A Trial of Telmisartan Prevention of Cardiovascular Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,228 (actual)
• Sponsor: Kumamoto University · Academic / Other
• Sex: All
• Age: 40 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The present research is conducted as a randomized, parallel-group, controlled, open study (using the PROBE method) to primarily verify the effects on various biomarkers in high-risk hypertensive patients treated with ARB (telmisartan, ARB group) as compared with those in patients receiving ordinary therapy (non-ARB group (ordinary therapy group)). In addition, onset of cardiovascular events and levels of markers that are associated with cardiovascular events are observed over time to examine the significance of each marker. The biomarkers will be obtained at the start of the study (at registration), after 6, 12, 24 and 36 months from the start of the study.

Detailed description

Events are defined as follows; Cerebrovascular events: Stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, unknown type of stroke), transient ischemic attack Coronary events: Myocardial infarction, angina pectoris, asymptomatic myocardial ischemia Cardiac events: Myocardial infarction, angina pectoris, asymptomatic myocardial ischemia, heart failure Aortic/peripheral arterial events: Aortic aneurysm, aortic dissection, arteriosclerotic disease (aorta, carotid artery, renal artery, mesenteric artery, peripheral artery, etc.) Complications of diabetes: Diabetic nephropathy\*, diabetic retinopathy\*, diabetic neuropathy\* Aggravation of renal function: Doubling of serum creatinine level, ESRD (initiation of dialysis, renal transplantation) \*Newly occurred or aggravated The followings will be measured as biomarkers; urinary albumin creatinine rates (UACR), plasma brain natriuretic peptide (BNP), urinary 8-hydroxy-deoxy-guanosine (8-OHdG), serum adiponectin, serum high-molecular weight adiponectin, high sensitivity c-reactive protein (hsCRP), estimated glomerular filtration rate (eGFR)

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Non-ARB (standard therapy)	Blood pressure lowering therapy except ARB
DRUG	ARB (Telmisartan)	Telmisartan 20-80 mg/day

Timeline

• Start date: 2009-07-01
• Primary completion: 2015-02-01
• Completion: 2016-03-01
• First posted: 2010-02-25
• Last updated: 2016-09-07

Locations

1 site across 1 country: Japan