Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Hypertension (office systolic blood pressure \> 135 mmHg), untreated or poorly controlled but stable antihypertensive regimen for \>/= 4 weeks
Presence of type 2 diabetes mellitus or target organ damage (echocardiographic or electrocardiographic left ventricular hypertrophy or microalbuminuria)
Presence of a metabolic syndrome, i.e at least two of the following \[(from letter (a) to letter(d)\] in patients with organ damage or at least one of the following \[from letter (b) to letter (d)\] in patients with diabetes mellitus: (a) impaired glucose tolerance (fasting plasma glucose 110 -125 mg/dl) (b )raised serum triglycerides (\>/= 150 mg/dl) or comitant use of statins for this indication(c) low HDL cholesterol (males: \< 40 mg/dl, females: \< 50 mg/dl)(d) waist circumference \>102 cm in men and \>88 cm in women
Age: 18-75 years
Negative pregnancy test in females
Written informed consent
You may not be if
Concomitant treatment with AT1-antagonists e.g. losartan, eprosartan, telmisartan) or calcium-antagonists (e.g. amlodipine, felodipine, isradipine, nifedipine, nimodipine).
Concomitant treatment with any other antihypertensive medication that cannot be safely withdrawn at entry (i.e taken on a stable regimen for \>/= 4 week) and that won't possibly be kept stable over the whole duration of the study.
Concomitant treatment with known cytochrome P450-3A4 inhibitors (e.g cimetidine, anti-HIV protease inhibitors e.g. ritonavir, azole anti-mycotics eg. Ketoconazole, digoxin, quinidine, tacrolimus) or inducers such as anti-epileptic drugs (eg. phenytoin, carbamazepine and phenobarbitone) or rifampicin
Concomitant treatment with potassium sparingdiuretics.
Malignant, severe or labile essential hypertension, orthostatic hypotension
Cardiovascular shock
Evidence of secondary form of hypertension, including coarctation of the aorta, hyperaldosteronism, renal artery stenosis or pheochromocytoma
Myocardial infarction or unstable angina within the previous 12 months
Severe cardiac valve disease
Severe rhythm or conduction disorder:
Cerebrovascular ischaemic event (stroke, transient ischaemic attack) within the previous 12 months
History of intra-cerebral haemorrhage or sub-arachnoid haemorrhage within the previous 12 months
Type 1 diabetes mellitus
Proteinuria (determined by uristix)
BMI \> 34
Uncorrected hypokalemia or hyperkalemia, potassium outside the range 3.0 to 5.5 mmol/l
Sodium depletion and/or hypovolemia
Gastrointestinal disease resulting in the potential for malabsorption)
Liver disease or transaminase (AST, ALT) levels \> 3 x the upper limit of normal range.
Renal failure, creatinine \>2.0 mg/dl
Clareo Health | Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control.
