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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
405
Tablets 20 Mg daily for 4 weeks then combination therapy
Tablets 80 Mg daily for 4 weeks then combination therapy
2 drugs (20 Mg Nifedipine/80 Mg Telmisartan) Combination therapy since the beginning
Unnamed facility
Pozzilli, Isernia, Italy
Unnamed facility
Monza, Monza-Brianza, Italy
Unnamed facility
Somma Lombardo, Varese, Italy
Unnamed facility
Ancona, Italy
Unnamed facility
Bologna, Italy
Unnamed facility
Brescia, Italy
Unnamed facility
Broni, Italy
Unnamed facility
Catania, Italy
Unnamed facility
Cinisello Balsamo, Italy
Unnamed facility
Ferrara, Italy
...and 33 more locations
The primary efficacy parameter will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: at 16 weeks of treatment compared to baseline
Office blood pressure, response rate (> 10mmHg decrease control rate (< 130/80) mean SBP, mean DBP.
Time frame: 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
Time frame: 8, 16 and 24 weeks
Microalbuminuria in subgroup (any reduction)
Time frame: 8, 16 and 24 weeks
Metabolic parameters: fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides
Time frame: 8, 16 and 24 weeks
Inflammatory markers: sRAGE (soluble receptors for advanced glycation end products) eotaxin-3, CRP (C-Reactive Protein)
Time frame: 8, 16 and 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.