A Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients
NCT ID: NCT00538486
Last Updated: 2013-05-14
Study Results
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Basic Information
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COMPLETED
PHASE4
360 participants
INTERVENTIONAL
2008-02-29
2009-06-30
Brief Summary
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Aside from their antihypertensive effects, angiotensin II receptor blockers (ARB) were shown to improve insulin sensitivity. Furthermore, metformin is commonly used to treat the obese type 2 diabetes mellitus. Metformin can also lower body weight and increase insulin sensitivity. In a prospective, double-blind, double-dummy, randomized, parallel-group study, we will evaluate the effects of ARB (telmisartan and candesartan) or amlodipine combination with metformin on weight gain, visceral fat, and metabolic parameters in obese hypertensive patients without diabetes mellitus compared with obese hypertensives on ARB or amlodipine treatment alone. This study will help to develop future comprehensive treatment strategies and guidelines for obesity related hypertension.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group T
Telmisartan
Telmisartan
Telmisartan 80mg 1/d
Group T+M
Telmisartan plus Metformin
Telmisartan plus Metformin
Telmisartan 80mg 1/d, Metformin 250mg 2/d
Group C
Candesartan
Candesartan
Candesartan 8mg daily
Group C+M
Candesartan pus Metformin
Candesartan plus Metformin
Candesartan 8mg 1/d Metformin 250mg 2/d
Group A
Amlodipine
Amlodipine
Amlodipine 5mg 1/d
Group A+M
Amlodipine plus Metformin
Amlodipine plus Metformin
Amlodipine 5mg 1/d, Metformin 250mg 2/d
Interventions
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Telmisartan plus Metformin
Telmisartan 80mg 1/d, Metformin 250mg 2/d
Telmisartan
Telmisartan 80mg 1/d
Candesartan
Candesartan 8mg daily
Candesartan plus Metformin
Candesartan 8mg 1/d Metformin 250mg 2/d
Amlodipine
Amlodipine 5mg 1/d
Amlodipine plus Metformin
Amlodipine 5mg 1/d, Metformin 250mg 2/d
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Waist circumference higher than 90cm in men, 80cm in women
Exclusion Criteria
* Grade 3 hypertension: SBP≥180mmHg, or DBP≥110mmHg
* known allergy or hypersensitivity to trial drugs
* Myocardial infarction or cerebrovascular accident in the year preceding the trial
* Clinical Congestive Heart Failure
* History of hepatitis or cirrhosis
* History of kidney disease
30 Years
70 Years
ALL
No
Sponsors
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Third Military Medical University
OTHER
Responsible Party
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Zhiming Zhu
Director of Dept. of Hypertension & Endocrinology
Principal Investigators
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Zhiming Zhu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The third hospital affiliated to the Third Military Medical University. China
Zhiming Zhu, MD, PhD
Role: STUDY_DIRECTOR
The third hospital affiliated to the Third Military Medical University. China
Locations
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The third hospital affiliated to the Third Military Medical University
Chongqing, , China
Countries
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References
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He H, Zhao Z, Chen J, Ni Y, Zhong J, Yan Z, Li Y, Liu D, Pletcher MJ, Zhu Z. Metformin-based treatment for obesity-related hypertension: a randomized, double-blind, placebo-controlled trial. J Hypertens. 2012 Jul;30(7):1430-9. doi: 10.1097/HJH.0b013e328353e249.
Other Identifiers
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HOT-ACME 1
Identifier Type: -
Identifier Source: org_study_id
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