Hypertension and dyslipidemia MedDRA version: 20.0 Level: HLT Classification code 10020774 Term: Vascular hypertensive disorders NEC System Organ Class: 100000004866 MedDRA version: 21.0 Level: LLT Classification code 10058110 Term: Dyslipidemia System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Triveram
Pharmaceutical Form: Tablet
INN or Proposed INN: ATORVASTATINA
CAS Number: 134523-03-8
Current Sponsor code: ND
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1-Men or women of any ethnic origin aged 40 to 79 years inclusive who have signed the informed consent form and can comply with the study requirements and timetable. 2-Essential hypertension defined as: Hypertensive patients naïve of treatment with 160 mmHg = SBP =65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: 1-Known symptomatic orthostatic hypotension 2-Secondary hypertension 3-Isolated diastolic hypertension defined as DBP > or = 90 mmHg 4-Known complicated hypertension: known stage III or IV hypertensive retinopathy, microalbuminaria 5-Known diabetes mellitus type I or type II 6-Obesity defined as a body mass index = 32 kg/m2 7-History or current presence of lymphedema or leg edema (unilateral or bilateral) of venous origin: previously known or discovered during the clinical examination at the selection visit, due to but not limited to calcium channel blockers, especially amlodipine (which induced amlodipine dose down titration or treatment stop) 8-Any history of stroke, transient ischemic attack, cerebrovascular surgery or history of coronary artery disease; heart failure (New York Heart Association [NYHA] II-IV), or hypertrophic obstructive myocardiopathy; unstable angina 9-Known ventricular rhythm disorders (except premature ventricular extrasystole less frequent than 6/minute); history of atrial fibrillation or atrial flutter (except if cured e.g. ablation without no new episodes within the last 12 months) or second or third degree A-V block or other cardiac rhythm disorders leading to important beat to beat variations in blood pressure or known valvular diseases (except mitral valve prolapse) 10-Known renal impairment moderate or severe (known creatinine clearance <60 mL/mn), or bilateral renal artery stenosis or stenosis to a solitary kidney 11-Contraindications to calcium channel inhibitors and/or to ACE inhibitors and/or to statins and especially: known allergy/hypersensitivity/history of intolerance, muscular toxicity during a treatment with a statin, hereditary or idiopathic angioedema, or history of angioedema associated with previous ACE inhibitor therapy 12-Any other medication which may be used for the treatment of hypertension, but which is currently being taken by the patient for an alternative indication, and which cannot be discontinued at the selection visit 13-History of myopathy, familial history of hereditary muscular disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of oral fixed-dose combination atorvastatin/amlodipine/perindopril versus the reference drug atorvastatin/amlodipine in lowering office sitting systolic blood pressure (SBP) after 12 weeks of treatment (W012) versus baseline (W012-W000).;Secondary Objective: -To assess the efficacy of atorvastatin / amlodipine / perindopril versus atorvastatin / amlodipine in lowering Diastolic Blood Pressure (DBP) after 12 weeks of treatment versus baseline (W012-W000). -To assess the efficacy of atorvastatin/ amlodipine/ perindopril in lowering Low Density Lipoprotein-Cholesterol (LDL-c) after 12 weeks of treatment versus baseline (W012-W000) within group -To assess the safety of each dose of atorvastatin/ amlodipine/ perindopril during the study and at the end of the treatment period (W012).;Primary end point(s): Office sitting Sistolic blood pressure( SBP) measured within 24 ± 3 hours after the last drug intake in the Investigator’s office using an automated validated device;Timepoint(s) of evaluation of this end point: All visits (W000,W004 e W012) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy. Office sitting DBP measured within 24 ¿ 3 hours after the last drug intake in the Investigator¿s office using an automated validated device; Efficacy. Change from baseline over 12 weeks in LDL-c, total cholesterol, high density lipoprotein-c (HDL-c), and triglycerides; Safety. Adverse events; Safety. Vital signs including BP postural changes ; Safety. Clinical laboratory parameters (biochemistry and haematology); Safety. Electrocardiogram (ECG);Timepoint(s) of evaluation of this end point: All visits (W000, W004 e W012); Inclusion W004 and W012; All visits; All visits; At W004; Inclusion and W012 | — |
Countries
Argentina, Brazil, Bulgaria, Italy, Korea, Republic of, Mexico, Russian Federation
Contacts
Public ContactProject Manager Sabrina Ceccotti
ISTITUTO DI RICERCA SERVIER S.R.L.
Outcome results
None listed