arterial hypertension high blood pressure
Conditions
Interventions
Blood samples will be taken during the study for haematology and biochemistry
at selection (+ * GCH test, for non-menopausal women only), M3, M6, M7 (only
simplified biochemistry) and M14. Approxima
Sponsors
Servier R&D Benelux
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Selection Patients women and men of at least 18 years with BMI*30: For untreated patients: 150*SBP
Exclusion criteria
Exclusion criteria: Selection Patients treated with more than 2 antihypertensive drugs at the selection visit or treated with Perindopril arginine/Amlodipine or Valsartan/Amlodipine free or fixed combination at the highest available doses (P10/A 10 mg or V160/A10 mg). History of intolerance with one or several study drugs Contraindication for using the study drugs History of acute episode of cerebrovascular disease, acute episode of heart disease alcholism or drug abuse Secondary hypertension , known symptomatic orthostatic hypotension Pregnancy, breastfeeding or possibilty to become pregnant during the study;Inclusionvisit Presence on the selection ECG of ventricular rhytm disorders: twisting spikes, ventricular tachycardia, ventricular extra-systoles (except for isolated occurence) or atrial fibrillation or atrial flutter or other cardiac rhytm disorders leading to important beat-to-beat variations in blood pressure Positive orthostatic test at inclusion Selection Laboratory result unavailable Hyponatraemia (150 mmol/L), hypokalaemia (5.8 mmol/L). Creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy end point Mean change from baseline to M3 of supine systolic BP measured at trough in the investigator*s office using an automatic validated device. Primary Safety End Points * Emergent Adverse Events occurring during the double blind period of the study (until M6) * Leg oedema assessment by the investigator * Clinically significant orthostatic hypotension evaluation * Clinically significant biochemical and haematological abnormalities | — |
Secondary
| Measure | Time frame |
|---|---|
| Office blood pressure Mean changes from baseline in: - Mean Supine Diastolic blood pressure - Controlled blood pressure - Response rate to treatment Definitions are provided in section 11 Efficacy measurements. Ambulatory blood pressure monitoring Change from baseline for the following parameters: -mean systolic blood pressure over 24 hours (main ABPM criterion). Tertiary end points see protocol p26 | — |
Countries
Netherlands
Outcome results
None listed