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NCT Number: 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

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The third hospital affiliated to the Third Military Medical University

Chongqing, 400042, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telmisartan plus Metformin

Drug

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

Telmisartan

Drug

Telmisartan 80mg 1/d

Other names: Telmisartan Alone

Candesartan

Drug

Candesartan 8mg daily

Other names: Candesartan Alone

Candesartan plus Metformin

Drug

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

Amlodipine

Drug

Amlodipine 5mg 1/d

Other names: Amlodipine alone

Amlodipine plus Metformin

Drug

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Official study title

Which is the Best Treatment for Non-diabetic Hypertension With Obesity: Telmisartan, Amlodipine or Candesartan, Alone or Plus MEtformin? (HOT-ACME 1)

Acronym: HOT-ACME

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 2, 2007
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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