Hypertension
Conditions
Brief summary
Patients having uncontrolled or poorly controlled hypertension are at risk of experiencing cardiovascular events such as myocardial infarction or stroke. To reduce this risk an appropriate antihypertensive therapy should allow to reach a target blood pressure of less than 130/80 mmHg in order to maximise cardiovascular protection.The purpose of this study is to 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.The primary efficacy parameter will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring (ABPM) at 16 weeks of treatment compared to baseline
Interventions
DRUGNifidipine
Tablets 20 Mg daily for 4 weeks then combination therapy
DRUGTelmisartan
Tablets 80 Mg daily for 4 weeks then combination therapy
DRUGNifedipine/Telmisartan
2 drugs (20 Mg Nifedipine/80 Mg Telmisartan) Combination therapy since the beginning
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 \[(from letter (a) to letter(d)\] 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
Exclusion criteria
* 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 * General
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy parameter will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring (ABPM) | at 16 weeks of treatment compared to baseline |
Secondary
| Measure | Time frame |
|---|---|
| Office blood pressure, response rate (> 10mmHg decrease control rate (< 130/80) mean SBP, mean DBP. | 8, 16 weeks of treatment |
| ABPM: % patients achieving BP < 125/80 mmHg morning BP increase/surge,24h mean diastolic BP,day average BP, night average BP,BP variability, pulse pressure through to peak ratio,smoothness index dipping or non dipping | 8, 16 and 24 weeks |
| Microalbuminuria in subgroup (any reduction) | 8, 16 and 24 weeks |
| Metabolic parameters: fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides | 8, 16 and 24 weeks |
| Inflammatory markers: sRAGE (soluble receptors for advanced glycation end products) eotaxin-3, CRP (C-Reactive Protein) | 8, 16 and 24 weeks |
Countries
Italy, Spain
Outcome results
None listed