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.
- Conditions
- arterial hypertensionhigh blood pressure10057166
- Registration Number
- NL-OMON34436
- Lead Sponsor
- Servier R&D Benelux
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
Selection
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
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 (<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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficacy end point<br /><br>Mean change from baseline to M3 of supine systolic BP measured at trough in the<br /><br>investigator*s office using an automatic validated device.<br /><br><br /><br>Primary Safety End Points<br /><br>* Emergent Adverse Events occurring during the double blind period of the study<br /><br>(until M6)<br /><br>* Leg oedema assessment by the investigator<br /><br>* Clinically significant orthostatic hypotension evaluation<br /><br>* Clinically significant biochemical and haematological abnormalities</p><br>
- Secondary Outcome Measures
Name Time Method <p>Office blood pressure<br /><br>Mean changes from baseline in:<br /><br>- Mean Supine Diastolic blood pressure<br /><br>- Controlled blood pressure<br /><br>- Response rate to treatment<br /><br>Definitions are provided in section 11 Efficacy measurements.<br /><br><br /><br>Ambulatory blood pressure monitoring<br /><br>Change from baseline for the following parameters:<br /><br>-mean systolic blood pressure over 24 hours (main ABPM criterion).<br /><br><br /><br>Tertiary end points see protocol p26</p><br>