Hypertension MedDRA version: 6.1 Level: PT Classification code 10020772
Conditions
Interventions
Trade Name: ADALAT CRONO
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: nifedipine GITS
CAS Number: 21829-25-4
Current Sponsor code: BAY a 1040
Concentration unit: mg milligram(s)
C
Sponsors
BAYER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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: (a) impaired glucose tolerance (fasting plasma glucose 110 ? 125 mg/dl) (b) raised serum triglycerides (>= 150 mg/dl) (c) low HDL cholesterol (males: 102 cm in men and >88 cm in women - Age: 18-75 years - Negative pregnancy test in females - Written informed 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
Exclusion criteria
Exclusion criteria: - Ongoing treatment with the following drugs: ACE-inhibitors (e.g. captopril, benazepril, enalapril, lisinopril, fosinopril, ramipril, perindopril, quinapril, moexipril, and trandolapril), AT1-antagonists (e.g. losartan, candesartan, eprosartan, telmisartan) or calcium-antagonists (e.g. amlodipine, felodipine, isradipine, nifedipine, nimodipine) that cannot be withdrawn. - Concomitant treatment with other antihypertensive medication that cannot be safely withdrawn at entry. - 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 sparing diuretics. - 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: - bradycardia on physical examination at rest (HR 100/min) - frequent complex ventricular arrythmias - atrial fibrillation - intraventricular conduction disorders, Wolf Parkinson White syndrome - sino-atrial, second degree or third degree A-V block - baseline QTc > 450 msec - 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. - Severe gastrointestinal tract narrowing - Kock pouch (ileostomy after proctocolectomy) - Cholestasis or biliary obstruction - Liver disease or transaminase (AST, ALT) levels > 3 x the upper limit of normal range. - Renal failure, creatinine >2.0 mg/dl - Any malignant disease that has required treatment within the last five years. - Dementia or psychosis. - History of non-compliance, alcoholism or drug abuse. - Treatment with any other investigational drug in the 30 days prior to entering the study. - Pregnancy and lactation - Known state of allergy, hypersensitivity to nifedipine or any other dihydropyridine or to telmisartan - Any surgical or medical condition which, at the discretion of the investigator, place the subject at higher risk from his/her participation in the study or are likely to prevent the subject from complying with the requirements of the study or completing the trial period. - History of non compliance to medical regimens or subjects unwilling to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy in blood pressure control when anti-hypertensive therapy is initiated with a combination of low dose Nifedipine GITS and Telmisartan compared to a regimen starting with monotherapy before adding the other drug.;Secondary Objective: The effect of treatment on the metabolic and inflammation markers as indicators of cardiovascular risk will also be assessed.;Primary end point(s): La valutazione dell?end-point sara' effettuata in cieco. | — |
Countries
Italy, Spain
Outcome results
None listed