A 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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00538486
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : May 14, 2013
Information provided by (Responsible Party):
Zhiming Zhu, Third Military Medical University

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.

Condition or disease Intervention/treatment Phase
Hypertension Obesity Drug: Telmisartan plus Metformin Drug: Telmisartan Drug: Candesartan Drug: Candesartan plus Metformin Drug: Amlodipine Drug: Amlodipine plus Metformin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group T
Drug: Telmisartan
Telmisartan 80mg 1/d
Other Name: Telmisartan Alone
Experimental: Group T+M
Telmisartan plus Metformin
Drug: Telmisartan plus Metformin
Telmisartan 80mg 1/d, Metformin 250mg 2/d
Experimental: Group C
Drug: Candesartan
Candesartan 8mg daily
Other Name: Candesartan Alone
Experimental: Group C+M
Candesartan pus Metformin
Drug: Candesartan plus Metformin
Candesartan 8mg 1/d Metformin 250mg 2/d
Active Comparator: Group A
Drug: Amlodipine
Amlodipine 5mg 1/d
Other Name: Amlodipine alone
Experimental: Group A+M
Amlodipine plus Metformin
Drug: Amlodipine plus Metformin
Amlodipine 5mg 1/d, Metformin 250mg 2/d

Primary Outcome Measures :
  1. Blood Pressure [ Time Frame: Baseline, 24 weeks(End of trial) ]
  2. Metabolic profiles, including lipid profile and blood glucose [ Time Frame: Baseline, 24 weeks(End of trial) ]

Secondary Outcome Measures :
  1. Abdominal fat assessed by CT [ Time Frame: Baseline, 24 weeks(End of trial) ]
  2. Obesity parameters, including waist circumference (WC) and body mass index (BMI) [ Time Frame: Baseline, 24 weeks(End of trial) ]
  3. Insulin resistance assessed by fasting serum insulin and HOMA-IR [ Time Frame: Baseline, 24 weeks(End of trial) ]
  4. Incidents of side effects between groups [ Time Frame: Baseline, 24 weeks(End of trial) ]

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00538486

The third hospital affiliated to the Third Military Medical University
Chongqing, China, 400042
Sponsors and Collaborators
Third Military Medical University
Principal Investigator: Zhiming Zhu, MD, PhD The third hospital affiliated to the Third Military Medical University. China
Study Director: Zhiming Zhu, MD, PhD The third hospital affiliated to the Third Military Medical University. China

Publications of Results:
Responsible Party: Zhiming Zhu, Director of Dept. of Hypertension & Endocrinology, Third Military Medical University Identifier: NCT00538486     History of Changes
Other Study ID Numbers: HOT-ACME 1
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013

Keywords provided by Zhiming Zhu, Third Military Medical University:
Abdominal obesity

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms
Candesartan cilexetil
Hypoglycemic Agents
Physiological Effects of Drugs
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists