A 36 wk three-center double-blind randomized three-way cross-over trial comparing metabolic effects of candesartan, hydrochlorothiazide and placebo.The MEDICA study Mechanisms for the diabetes-preventing effect of candesartan - The MEDICA study

meå University Hospital0 个研究点目标入组 24 人开始时间: 2004年12月22日最近更新: 2012年3月19日

适应症

试验速览

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•Male and female patients between 18 and 70 years old with:
•- hypertension diagnosed or treated since three months or more. Blood pressure at visit 2 equal to or more than 140/90 but not above 170/105 mmHg. (Visit 2 is the randomization visit. The patients have then been on placebo hypertensive treatment for a varying period of time. Blood pressure has been measured every two weeks).
•- abdominal obesity difines as waist circumference greater than or equal to 102 cm (males) or 88 cm (females)
•- written consent
•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

•- Uncontrolled hypertension, treated or non-treated with a SP >170 or DP >105 mmHg (at screening or during the placebo run-in period)
•- Diabetes mellitus, previously diagnosed or indicated by fasting or 2h OGTT plasma glucose levels
•- Any history of coronary heart or cerebrovascular disease
•- Cardiac failure at stages NHYA II-IV
•- Severe liver disease (e.g. ASAT and/or ALAT >3* upperlimit of normal range)
•- Modest-severe impairment in renal function (S-creatinine >150 micromol/L)
•- Uncontrolled endocrine disorders
•- Previous (within 5 years) or ongoing malignancy
•- Recent or ongoing alcohol or drug abuse (within 6 months before screening)
•- Ongoing or recent treatment wiwth fibrates (within 2 months)
•- Ongoing treatment with antiobesity drugs
•- Ongoing systemic treatment with ant-inflammatory drugs, NSAIDs and steroids
•- Pregnancy (or in non post-menopausal females) insufficient anticonception
•- Received an investigational drug within 2 months prior to screening
•- Any disease that according to teh investigator could be adversely affected by the study
•- Any patient that the investigator considers unsuitable to participate in the study

发起方

meå University Hospital