NCT00538486

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Third Military Medical University · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• Obesity

Interventions

Type	Name	Description
DRUG	Telmisartan plus Metformin	Telmisartan 80mg 1/d, Metformin 250mg 2/d
DRUG	Telmisartan	Telmisartan 80mg 1/d
DRUG	Candesartan	Candesartan 8mg daily
DRUG	Candesartan plus Metformin	Candesartan 8mg 1/d Metformin 250mg 2/d
DRUG	Amlodipine	Amlodipine 5mg 1/d
DRUG	Amlodipine plus Metformin	Amlodipine 5mg 1/d, Metformin 250mg 2/d

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-10-02
• Last updated: 2013-05-14

Locations

1 site across 1 country: China