Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhiming Zhu, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT00538486
First received: October 1, 2007
Last updated: May 12, 2013
Last verified: May 2013

October 1, 2007
May 12, 2013
February 2008
June 2009   (final data collection date for primary outcome measure)
  • 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 ]
1. Blood Pressure 2. Metabolic profiles, including lipid profile and blood glucose [ Time Frame: Baseline, 12weeks(End of trial) ]
Complete list of historical versions of study NCT00538486 on ClinicalTrials.gov Archive Site
  • 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 ]
1. Abdominal fat assessed by CT 2. Obesity parameters, including waist circumference (WC) and body mass index (BMI) 3. Insulin resistance assessed by fasting serum insulin and HOMA-IR [ Time Frame: Baseline, 12weeks(End of trial) ]
Not Provided
Not Provided
 
A Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients
Which is the Best Treatment for Non-diabetic Hypertension With Obesity: Telmisartan, Amlodipine or Candesartan, Alone or Plus MEtformin? (HOT-ACME 1)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hypertension
  • Obesity
  • Drug: Telmisartan plus Metformin
    Telmisartan 80mg 1/d, Metformin 250mg 2/d
    Other Name: Telmisartan Plus Metformin
  • Drug: Telmisartan
    Telmisartan 80mg 1/d
    Other Name: Telmisartan Alone
  • Drug: Candesartan
    Candesartan 8mg daily
    Other Name: Candesartan Alone
  • Drug: Candesartan plus Metformin
    Candesartan 8mg 1/d Metformin 250mg 2/d
    Other Name: Candesartan Plus Metformin
  • Drug: Amlodipine
    Amlodipine 5mg 1/d
    Other Name: Amlodipine alone
  • Drug: Amlodipine plus Metformin
    Amlodipine 5mg 1/d, Metformin 250mg 2/d
    Other Name: Amlodipine plus Metformin
  • Experimental: Group T
    Telmisartan
    Intervention: Drug: Telmisartan
  • Experimental: Group T+M
    Telmisartan plus Metformin
    Intervention: Drug: Telmisartan plus Metformin
  • Experimental: Group C
    Candesartan
    Intervention: Drug: Candesartan
  • Experimental: Group C+M
    Candesartan pus Metformin
    Intervention: Drug: Candesartan plus Metformin
  • Active Comparator: Group A
    Amlodipine
    Intervention: Drug: Amlodipine
  • Experimental: Group A+M
    Amlodipine plus Metformin
    Intervention: Drug: Amlodipine plus Metformin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00538486
HOT-ACME 1
Yes
Zhiming Zhu, Third Military Medical University
Third Military Medical University
Not Provided
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
Third Military Medical University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP