Back to resultsA Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients (HOT-ACME)
Primary Purpose
Hypertension, Obesity
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Telmisartan plus Metformin
Telmisartan
Candesartan
Candesartan plus Metformin
Amlodipine
Amlodipine plus Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Abdominal obesity, Treatment
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
Sites / Locations
- The third hospital affiliated to the Third Military Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Experimental
Arm Label
Group T
Group T+M
Group C
Group C+M
Group A
Group A+M
Arm Description
Telmisartan
Telmisartan plus Metformin
Candesartan
Candesartan pus Metformin
Amlodipine
Amlodipine plus Metformin
Outcomes
Primary Outcome Measures
Blood Pressure
Metabolic profiles, including lipid profile and blood glucose
Secondary Outcome Measures
Abdominal fat assessed by CT
Obesity parameters, including waist circumference (WC) and body mass index (BMI)
Insulin resistance assessed by fasting serum insulin and HOMA-IR
Incidents of side effects between groups
Full Information
NCT ID
NCT00538486
First Posted
October 1, 2007
Last Updated
May 12, 2013
Sponsor
Third Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT00538486
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
Acronym
HOT-ACME
Official Title
Which is the Best Treatment for Non-diabetic Hypertension With Obesity: Telmisartan, Amlodipine or Candesartan, Alone or Plus MEtformin? (HOT-ACME 1)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Obesity
Keywords
Hypertension, Abdominal obesity, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group T
Arm Type
Experimental
Arm Description
Telmisartan
Arm Title
Group T+M
Arm Type
Experimental
Arm Description
Telmisartan plus Metformin
Arm Title
Group C
Arm Type
Experimental
Arm Description
Candesartan
Arm Title
Group C+M
Arm Type
Experimental
Arm Description
Candesartan pus Metformin
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Amlodipine
Arm Title
Group A+M
Arm Type
Experimental
Arm Description
Amlodipine plus Metformin
Intervention Type
Drug
Intervention Name(s)
Telmisartan plus Metformin
Intervention Description
Telmisartan 80mg 1/d, Metformin 250mg 2/d
Intervention Type
Drug
Intervention Name(s)
Telmisartan
Other Intervention Name(s)
Telmisartan Alone
Intervention Description
Telmisartan 80mg 1/d
Intervention Type
Drug
Intervention Name(s)
Candesartan
Other Intervention Name(s)
Candesartan Alone
Intervention Description
Candesartan 8mg daily
Intervention Type
Drug
Intervention Name(s)
Candesartan plus Metformin
Intervention Description
Candesartan 8mg 1/d Metformin 250mg 2/d
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Other Intervention Name(s)
Amlodipine alone
Intervention Description
Amlodipine 5mg 1/d
Intervention Type
Drug
Intervention Name(s)
Amlodipine plus Metformin
Intervention Description
Amlodipine 5mg 1/d, Metformin 250mg 2/d
Primary Outcome Measure Information:
Title
Blood Pressure
Time Frame
Baseline, 24 weeks(End of trial)
Title
Metabolic profiles, including lipid profile and blood glucose
Time Frame
Baseline, 24 weeks(End of trial)
Secondary Outcome Measure Information:
Title
Abdominal fat assessed by CT
Time Frame
Baseline, 24 weeks(End of trial)
Title
Obesity parameters, including waist circumference (WC) and body mass index (BMI)
Time Frame
Baseline, 24 weeks(End of trial)
Title
Insulin resistance assessed by fasting serum insulin and HOMA-IR
Time Frame
Baseline, 24 weeks(End of trial)
Title
Incidents of side effects between groups
Time Frame
Baseline, 24 weeks(End of trial)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiming Zhu, MD, PhD
Organizational Affiliation
The third hospital affiliated to the Third Military Medical University. China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhiming Zhu, MD, PhD
Organizational Affiliation
The third hospital affiliated to the Third Military Medical University. China
Official's Role
Study Director
Facility Information:
Facility Name
The third hospital affiliated to the Third Military Medical University
City
Chongqing
ZIP/Postal Code
400042
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
22525206
Citation
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.
Results Reference
result
Learn more about this trial
A Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients
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