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HypertensionPhase 4HOT-ACMENCT00538486

A Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients

A Phase 4 study testing Telmisartan plus Metformin, Telmisartan and Candesartan in people with Hypertension and Obesity, run by Third Military Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Hypertension, Obesity
What is being tested?
Telmisartan plus Metformin, Telmisartan and Candesartan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteChina
Study dates
Feb 2008to Jun 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Grade 1 or 2 hypertension: 140mmHg≤SBP<180mmHg, and/or 90mmHg≤DBP<110mmHg
  • Waist circumference higher than 90cm in men, 80cm in women

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The third hospital affiliated to the Third Military Medical University

    Chongqing, 400042

Other trials in China

About this study

Official title: 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.

Being tested
Telmisartan plus Metformin, Telmisartan, Candesartan, Candesartan plus Metformin, Amlodipine
Keywords
Hypertension, Abdominal obesity, Treatment
Medical subject headings
Hypertension, Obesity, Obesity, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telmisartan plus MetforminDrug

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

  • TelmisartanDrug

    Also called Telmisartan Alone

    Telmisartan 80mg 1/d

  • CandesartanDrug

    Also called Candesartan Alone

    Candesartan 8mg daily

  • Candesartan plus MetforminDrug

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

  • AmlodipineDrug

    Also called Amlodipine alone

    Amlodipine 5mg 1/d

  • Amlodipine plus MetforminDrug

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

Study groups in NCT00538486
Study groupRoleWhat they receive
Group TExperimentalTelmisartan
Receives: Drug: Telmisartan
Group T+MExperimentalTelmisartan plus Metformin
Receives: Drug: Telmisartan plus Metformin
Group CExperimentalCandesartan
Receives: Drug: Candesartan
Group C+MExperimentalCandesartan pus Metformin
Receives: Drug: Candesartan plus Metformin
Group AActive comparatorAmlodipine
Receives: Drug: Amlodipine
Group A+MExperimentalAmlodipine plus Metformin
Receives: Drug: Amlodipine plus Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Pressure

    Measured: Baseline, 24 weeks(End of trial)

  2. Metabolic profiles, including lipid profile and blood glucose

    Measured: Baseline, 24 weeks(End of trial)

Secondary outcomes (4)

  1. Abdominal fat assessed by CT

    Measured: Baseline, 24 weeks(End of trial)

  2. Obesity parameters, including waist circumference (WC) and body mass index (BMI)

    Measured: Baseline, 24 weeks(End of trial)

  3. Insulin resistance assessed by fasting serum insulin and HOMA-IR

    Measured: Baseline, 24 weeks(End of trial)

  4. Incidents of side effects between groups

    Measured: Baseline, 24 weeks(End of trial)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2007 (estimated)
  2. Study startFeb 2008
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00538486
Sponsor's protocol ID
HOT-ACME 1
Acronym
HOT-ACME
Status last verified
May 2013
First submitted
1 Oct 2007
Last updated
14 May 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22525206

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Telmisartan plus Metformin, Telmisartan and Candesartan in people with Hypertension and Obesity, run by Third Military Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure (time frame: Baseline, 24 weeks(End of trial)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00538486, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2013.

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