Efficacy and Safety of Fixed-Dose Combinationatorvastatin / amlodipine / perindopril versus Fixed-Dose Combination of atorvastatin / amlodipine in Patients with Hypertension and Dyslipidemia.

Phase 1

• Conditions: Hypertension and dyslipidemia; MedDRA version: 20.0Level: HLTClassification code 10020774Term: Vascular hypertensive disorders NECSystem Organ Class: 100000004866; MedDRA version: 21.0Level: LLTClassification code 10058110Term: DyslipidemiaSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-005378-12-IT
• Lead Sponsor: INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-09-08
• Study Start: 2021-09-01
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 854

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 <180 mmHg and 100 mmHg = DBP < 110 mmHg or isolated systolic hypertension (160 mmHg = SBP <180 mmHg) or
Uncontrolled hypertensive patients currently under monotherapy treatment within at least 4 weeks (except patients treated by perindopril 10mg or amlodipine 10mg) for combined systolic and diastolic hypertension (150 mmHg = SBP < 180 mmHg and 95 mmHg = DBP < 110 mmHg) or isolated systolic hypertension (150 mmHg = SBP < 180 mmHg)
3-Dysplipidemic patients : naïve of treatment or uncontrolled with statin at lowest dose within at least 4 weeks with 130 mg/ Decilitre (dL) (or 3.36 millimole [mmol] /L) = LDL-c < 190 mg/dL (or 4.91 mmol/L) according to a prevous laboratory result within 12 months
4-Confirmed hypertension measured at inclusion: 150 mmHg = SBP < 180 mmHg and 95 mmHg = DBP < 110 mmHg or isolated systolic hypertension 150 mmHg = SBP < 180 mmHg for either patients under prior monotherapy treatment or patients naive of treatment
5-Confirmed dyslipidemia on lipid profile assessed at W0 visit: 130 mg/dL = LDL-c < 190 mg/dL
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified