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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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2013-05-14

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Third Military Medical University

    lead OTHER

Principal Investigators

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

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00538486 on ClinicalTrials.gov