Perindopril arginine/Amlodipine versus Valsartan/Amlodipine antihypertensive startegies: Efficacy and safety in mild to moderate hypertensive patients. A randomised, double blind 6-month study followed by 8-month open label long-term follow-up with Perindopril arginine/Amlodipine. - Efficacy/safety of Perindoprilarg./Amlodipine versus Valsartan/Amlodipine

Servier R&D Benelux0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Patients women and men of at least 18 years with BMI*30:
•For untreated patients: 150*SBP<180 mmHg and 95mmHg*DBP <110mmHg
•For treated patients with no more than2 antihypertensive drugs and who in the investigator*s opinion require a change in medication either because of insufficient efficacy or poor tolerability: SBP <160 mmHg and DBP<100 mmHg.;Inclusion visit
•After two weeks placebo run-in period 150*SBP<180 mmHg and 95mmHg*DBP <110mmHg
•Tablet compliance *70%and* 130%during placebo period

•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 (<135 mmol/L) or hypernatraemia (>150 mmol/L), hypokalaemia (<3.5 mmol/L) or hyperkalaemia (>5.8 mmol/L).
•Creatinine clearance <30ml/min,using Cockcroft*s formula
•ALAT or ASAT upper than 3 times the upper limit of normal laboratory range
•Positive pregnancy test (beta GCH) performed at selection visit

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