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

NCT00538486 | Completed Phase 4 DMC

• 1 other identifier: HOT-ACME 1
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Obesity

Keywords

Hypertension; Abdominal obesity; Treatment

Outcome Measures

Primary Outcomes (2)

• Blood Pressure

  Baseline, 24 weeks(End of trial)

• Metabolic profiles, including lipid profile and blood glucose

  Baseline, 24 weeks(End of trial)

Secondary Outcomes (4)

• Abdominal fat assessed by CT

  Baseline, 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-IR

  Baseline, 24 weeks(End of trial)

• Incidents of side effects between groups

  Baseline, 24 weeks(End of trial)

Study Arms (6)

Group T

EXPERIMENTAL

Telmisartan

Drug: Telmisartan

Group T+M

EXPERIMENTAL

Telmisartan plus Metformin

Drug: Telmisartan plus Metformin

Group C

EXPERIMENTAL

Candesartan

Drug: Candesartan

Group C+M

EXPERIMENTAL

Candesartan pus Metformin

Drug: Candesartan plus Metformin

Group A

ACTIVE COMPARATOR

Amlodipine

Drug: Amlodipine

Group A+M

EXPERIMENTAL

Amlodipine plus Metformin

Drug: Amlodipine plus Metformin

Interventions

Telmisartan plus Metformin DRUG

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

Group T+M

Telmisartan DRUG

Telmisartan 80mg 1/d

Also known as: Telmisartan Alone

Group T

Candesartan DRUG

Candesartan 8mg daily

Also known as: Candesartan Alone

Group C

Candesartan plus Metformin DRUG

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

Group C+M

Amlodipine DRUG

Amlodipine 5mg 1/d

Also known as: Amlodipine alone

Group A

Amlodipine plus Metformin DRUG

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

Group A+M

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

The third hospital affiliated to the Third Military Medical University

Chongqing, 400042, China

Location

Related Publications (1)

• 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.

  PMID: 22525206 RESULT

MeSH Terms

Conditions

Hypertension; Obesity; Obesity, Abdominal

Interventions

Telmisartan; Metformin; candesartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Zhiming Zhu, MD, PhD

  The third hospital affiliated to the Third Military Medical University. China

  PRINCIPAL INVESTIGATOR

• Zhiming Zhu, MD, PhD

  The third hospital affiliated to the Third Military Medical University. China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Dept. of Hypertension & Endocrinology

Study Record Dates

• First Submitted: October 1, 2007
• First Posted: October 2, 2007
• Study Start: February 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 14, 2013

Record last verified: 2013-05

Locations

CN (1)