Skip to content

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)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00538486
Acronym
HOT-ACME
Enrollment
360
Registered
2007-10-02
Start date
2008-02-29
Completion date
2009-06-30
Last updated
2013-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Obesity

Keywords

Hypertension, Abdominal obesity, Treatment

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.

Interventions

DRUGTelmisartan plus Metformin

Telmisartan 80mg 1/d, Metformin 250mg 2/d

DRUGTelmisartan

Telmisartan 80mg 1/d

DRUGCandesartan

Candesartan 8mg daily

DRUGCandesartan plus Metformin

Candesartan 8mg 1/d Metformin 250mg 2/d

DRUGAmlodipine

Amlodipine 5mg 1/d

DRUGAmlodipine plus Metformin

Amlodipine 5mg 1/d, Metformin 250mg 2/d

Sponsors

Third Military Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
Blood PressureBaseline, 24 weeks(End of trial)
Metabolic profiles, including lipid profile and blood glucoseBaseline, 24 weeks(End of trial)

Secondary

MeasureTime frame
Abdominal fat assessed by CTBaseline, 24 weeks(End of trial)
Obesity parameters, including waist circumference (WC) and body mass index (BMI)Baseline, 24 weeks(End of trial)
Insulin resistance assessed by fasting serum insulin and HOMA-IRBaseline, 24 weeks(End of trial)
Incidents of side effects between groupsBaseline, 24 weeks(End of trial)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026