Double-blind, randomised trial to investigate the antihypertensive and metabolic effects of candesartan in insulin-resistant obese patients with a hypertension not adequately controlled by previous beta-blocker or calcium channel blocker

Takeda Pharma GmbH0 sitesJuly 10, 2006

DrugsBlopress 8mg plus 12,5mg Blopress 16mg plus 12,5mg HCT HEXAL 12.5mg

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Takeda Pharma GmbH
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 10, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Takeda Pharma GmbH

Eligibility Criteria

Inclusion Criteria

•Outpatients aged from 35 to 70 years inclusive (men) and 45 to 70 years inclusive (women); Abdominal obesity with a waist circumference \> 102 cm (men) and \> 88 cm (women); Body mass index (BMI) \> 30 kg/m2; Hypertension not adequately controlled (seated diastolic blood pressure (DBP) \> 95 mmHg and \<\= 110 mmHg) by monotherapy with either beta\-blocker or calcium channel blocker; Homeostasis Model Assessment (HOMA)\-Insulin Resistance index \> 2\.5;
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•Existing HCT therapy at start of study; diabetes mellitus type 1 or 2\[known or newly detected (Screening:FPG\>7\.0mmol/L); Chronic renal impairment or S\-creatinine \>\= 1\.8 mg/dL;Presence of single kidney or state after kidney transplantation or known bilateral renal artery stenosis (RAS) or interventional treatment for RAS in the last year;Hyperkalaemia (potassium \>5\.5mmol/l); Nephrotic syndrome; Thyroid dysfunction; Primary or secondary hyperaldosteronismus; Cushing syndrome; Known or suspected familial hypercholesterolaemia; Severe hepatic impairment; History of chronic heart failure; History of overt coronary heart disease; History of silent myocardial infarction;Hemodynamically relevant stenosis of the mitral and/or aortic valve; History of stroke; Stage 3 hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg); ACE inhibitor or ARB therapy in the previous 4 weeks; Lipid\-lowering therapy with CSE inhibitors or anticipated initiation of such a therapy; History of autoimmune disease; History of cancer in the last 5 years or wasting disease; Pregnancy or breast feeding woman or woman wishing to become pregnant in the planned period of the study; Woman of childbearing potential not using highly effective methods of birth control (Note: A highly effective method of birth control is defined as those which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly; Breast feeding; Patients who are in a dependent relationship with the investigator or sponsor or may consent under stress.