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

• Conditions: Insulin-resistant obese patients with a hypertension not adequately controlled by previous beta-blocker or calcium channel blocker; MedDRA version: 8.1Level: LLTClassification code 10015488

• Registration Number: EUCTR2006-001998-25-DE
• Lead Sponsor: Takeda Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified