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)

May 12, 2013 updated by: Zhiming Zhu, Third Military Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chongqing, China, 400042
        • The third hospital affiliated to the Third Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group T
Telmisartan
Drug: Telmisartan
Telmisartan 80mg 1/d
Other Names:
  • Telmisartan Alone
EXPERIMENTAL: Group T+M
Telmisartan plus Metformin
Drug: Telmisartan plus Metformin
Telmisartan 80mg 1/d, Metformin 250mg 2/d
EXPERIMENTAL: Group C
Candesartan
Drug: Candesartan
Candesartan 8mg daily
Other Names:
  • 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
Amlodipine
Drug: Amlodipine
Amlodipine 5mg 1/d
Other Names:
  • Amlodipine alone
EXPERIMENTAL: Group A+M
Amlodipine plus Metformin
Drug: Amlodipine plus Metformin
Amlodipine 5mg 1/d, Metformin 250mg 2/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood Pressure
Time Frame: Baseline, 24 weeks(End of trial)
Baseline, 24 weeks(End of trial)
Metabolic profiles, including lipid profile and blood glucose
Time Frame: Baseline, 24 weeks(End of trial)
Baseline, 24 weeks(End of trial)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Military Medical University

Investigators

  • Study Director: Zhiming Zhu, MD, PhD, The third hospital affiliated to the Third Military Medical University. China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

October 1, 2007

First Submitted That Met QC Criteria

October 1, 2007

First Posted (ESTIMATE)

October 2, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 12, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOT-ACME 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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