Efficacy Study of Olmesartan Medoxomil on Coronary Atherosclerosis and Epicardial Adipose Tissue(EAT)
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|ClinicalTrials.gov Identifier: NCT02360956|
Recruitment Status : Unknown
Verified February 2015 by Yundai Chen, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : February 11, 2015
Last Update Posted : February 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Coronary Atherosclerosis||Drug: Olmesartan medoxomil tablets Drug: Antihypertensive medication (per doctor suggestion)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy Study of Olmesartan Medoxomil on Coronary Atherosclerosis Progression and Epicardial Adipose Tissue(EAT) Volume Reduction in Patients With Coronary Atherosclerosis Detected by Coronary CT Angiography(CCTA)|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
Experimental: Olmesartan medoxomil
Drug: Olmesartan medoxomil tablets(Daiichi Sankyo Inc, Japan). The initial dose is 20mg once daily. If blood pressure requiring further reduction after two weeks, olmesartan medoxomil may be increased to 40mg once daily.
Drug: Olmesartan medoxomil tablets
Dosage must be individualized. The usual recommended starting dose of Benicar is 20mg once daily when used as monotherapy in patients who are not volume-contracted.For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Benicar may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
Other Name: Benicar
Active Comparator: Antihypertensive medication
Drug:Any antihypertensive medication alone or in combination.Calcium channel blockers (CCBs),diuretics, beta-blockers, or other antihypertensive medication except angiotensin-Converting Enzyme Inhibitors inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs).
The drug dose must be individualized.
Drug: Antihypertensive medication (per doctor suggestion)
Any antihypertensive medication alone or in combination.Calcium channel blockers (CCBs),diuretics, beta-blockers, or other antihypertensive medication except ACE inhibitors or ARBs.The drug dose must be individualed.Dosage must be individualized.The patients should take the antihypertensive drugs according to doctors'suggestion.
Other Name: no other names
- Coronary atherosclerosis progression detected by CCTA [ Time Frame: 12 month ]Coronary atherosclerosis progression is defined as ≥10% diameter reduction or progression of a pre-existing coronary stenosis; or ≥0.2mm reduction or progression of the minimal luminal area (MLD) in the lesion
- Epicardial Adipose Tissue(EAT) volume detected by CCTA [ Time Frame: 12 month ]
- The relationship between coronary atherosclerosis and EAT, as indicated by coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume changes [ Time Frame: 12 month ]
- Serum levels of blood lipids [ Time Frame: 12 month ]Blood lipids include total cholesterol,triglyceride,high density lipoprotein(HDL) and low density lipoprotein(LDL).
- Serum levels of blood glucose [ Time Frame: 12 month ]Blood glucose is defined as fasting blood glucose(FBG).
- Circulating surrogate markers of atherosclerosis inflammation including hs-CRP,IL-6,MCP-1,TNF--α and MMP-9 [ Time Frame: 12 month ]CRP: C reactive protein; IL: Interleukin; MCP: Monocyte chemotactic protein,composite of chemoattractant markers; TNF-α: tumor necrosis factor; MMP: Matrix metalloproteinase.
- Individual circulating surrogate markers of endothelial function including NO and ET-1 [ Time Frame: 12 month ]ET: Endothelin
- Individual circulating surrogate markers of adipose tissue inflammation and metabolism including adiponectin and leptin. [ Time Frame: 12 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360956
|Contact: Zhou Yingfirstname.lastname@example.org|
|Chinese PLA General Hospital||Recruiting|
|Beijing, China, 100853|
|Contact: Chen Yundai 86-10-55499246 email@example.com|
|Principal Investigator:||Chen Yundai||Chinese PLA General Hospital|