Insulin-resistant obese patients with a hypertension not adequately controlled by previous beta-blocker or calcium channel blocker MedDRA version: 8.1 Level: LLT Classification code 10015488
Conditions
Interventions
Trade Name: Blopress 8mg plus 12,5mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Candesartan Cilexetil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-
INN o
Sponsors
Takeda Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of candesartan 16 mg + hydrochlorothiazide (HCT) 12.5 mg in blood pressure reduction in comparison to placebo + HCT 12.5 mg, both given on top of previously insufficiently effective beta-blocker or calcium channel blocker therapy;Secondary Objective: To determine the effect of candesartan 16 mg+ HCT 12.5 mg on glucose and lipid metabolism, inflammation (as assessed by the high sensitive C-reactive protein (hs-CRP)) and coronary risk (as assessed by Prospective Cardiovascular Muenster (PROCAM) risk score);Primary end point(s): Blood pressure (mean reduction in diastolic blood pressure measured at trough) after 6 months of treatment as compared to baseline | — |
Countries
Germany
Outcome results
None listed