A Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients | RxWiki

A Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients

Overview[ - collapse ][ - ]

Purpose	The epidemic of obesity is associated with a considerable rise in the incidence of the metabolic syndrome, type 2 diabetes mellitus, and hypertension. Insulin resistance plays an important role in the pathogenesis of obesity related hypertension. These patients are at high risk to suffer from cardiovascular events. However, current guidelines for treatment of hypertension do not provide specific recommendation for the pharmacotherapy of obese hypertensive patients due to lack of prospective randomized intervention studies in non-diabetic obese hypertensive patients. 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.
Condition	Hypertension Obesity
Intervention	Drug: Telmisartan plus Metformin Drug: Telmisartan Drug: Candesartan Drug: Candesartan plus Metformin Drug: Amlodipine Drug: Amlodipine plus Metformin
Phase	Phase 4
Sponsor	Third Military Medical University
Responsible Party	Third Military Medical University
ClinicalTrials.gov Identifier	NCT00538486
First Received	October 1, 2007
Last Updated	May 12, 2013
Last verified	May 2013

Tracking Information[ + expand ][ + ]

First Received Date	October 1, 2007
Last Updated Date	May 12, 2013
Start Date	February 2008
Estimated Primary Completion Date	June 2009
Current Primary Outcome Measures	Blood Pressure [Time Frame: Baseline, 24 weeks(End of trial)] [Designated as safety issue: No] Metabolic profiles, including lipid profile and blood glucose [Time Frame: Baseline, 24 weeks(End of trial)] [Designated as safety issue: No]
Current Secondary Outcome Measures	Abdominal fat assessed by CT [Time Frame: Baseline, 24 weeks(End of trial)] [Designated as safety issue: Yes] Obesity parameters, including waist circumference (WC) and body mass index (BMI) [Time Frame: Baseline, 24 weeks(End of trial)] [Designated as safety issue: Yes] Insulin resistance assessed by fasting serum insulin and HOMA-IR [Time Frame: Baseline, 24 weeks(End of trial)] [Designated as safety issue: Yes] Incidents of side effects between groups [Time Frame: Baseline, 24 weeks(End of trial)] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	A Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients
Official Title	Which is the Best Treatment for Non-diabetic Hypertension With Obesity: Telmisartan, Amlodipine or Candesartan, Alone or Plus MEtformin? (HOT-ACME 1)
Brief Summary	The epidemic of obesity is associated with a considerable rise in the incidence of the metabolic syndrome, type 2 diabetes mellitus, and hypertension. Insulin resistance plays an important role in the pathogenesis of obesity related hypertension. These patients are at high risk to suffer from cardiovascular events. However, current guidelines for treatment of hypertension do not provide specific recommendation for the pharmacotherapy of obese hypertensive patients due to lack of prospective randomized intervention studies in non-diabetic obese hypertensive patients. 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Hypertension Obesity
Intervention	Drug: Telmisartan plus Metformin Telmisartan 80mg 1/d, Metformin 250mg 2/d Other Names: Telmisartan Plus MetforminDrug: Telmisartan Telmisartan 80mg 1/d Other Names: Telmisartan AloneDrug: Candesartan Candesartan 8mg daily Other Names: Candesartan AloneDrug: Candesartan plus Metformin Candesartan 8mg 1/d Metformin 250mg 2/d Other Names: Candesartan Plus MetforminDrug: Amlodipine Amlodipine 5mg 1/d Other Names: Amlodipine aloneDrug: Amlodipine plus Metformin Amlodipine 5mg 1/d, Metformin 250mg 2/d Other Names: Amlodipine plus Metformin
Study Arm (s)	Experimental: Group T Telmisartan Experimental: Group T+M Telmisartan plus Metformin Experimental: Group C Candesartan Experimental: Group C+M Candesartan pus Metformin Active Comparator: Group A Amlodipine Experimental: Group A+M Amlodipine plus Metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	360
Estimated Completion Date	June 2009
Estimated Primary Completion Date	June 2009
Eligibility Criteria	Inclusion Criteria: - Grade 1 or 2 hypertension: 140mmHg≤SBP<180mmHg, and/or 90mmHg≤DBP<110mmHg - Waist circumference higher than 90cm in men, 80cm in women Exclusion Criteria: - Diabetes - 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
Gender	Both
Ages	30 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	China

Administrative Information[ + expand ][ + ]

NCT Number	NCT00538486
Other Study ID Numbers	HOT-ACME 1
Has Data Monitoring Committee	Yes
Information Provided By	Third Military Medical University
Study Sponsor	Third Military Medical University
Collaborators	Not Provided
Investigators	Principal Investigator: Zhiming Zhu, MD, PhD The third hospital affiliated to the Third Military Medical University. ChinaStudy Director: Zhiming Zhu, MD, PhD The third hospital affiliated to the Third Military Medical University. China
Verification Date	May 2013

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