Patients with mild to moderate essential arterial hypertension AND primary hypercholesterolemia or mixed dyslipidaemia (LDL-c < 4.9 mmol/L or <189.5 mg/dl) with moderate, high or very high risk for cardiovascular event. MedDRA version: 20.0 Level: PT Classification code 10062060 Term: Hyperlipidaemia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0
Conditions
Interventions
Trade Name: Ravalsyo®
Product Name: Ravalsyo
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: rosuvastatin
Other descriptive
Sponsors
KRKA, d.d., Novo mesto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with mild to moderate essential AH* AND primary hypercholesterolemia or mixed dyslipidaemia (LDL-c =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • Patients unsuccessfully treated with 2 or more different active substances at once for lowering blood pressure whenever in the past. • Secondary AH (e.g. pheochromocytoma, primary aldosteronism, renal artery stenosis). • Suspected resistant hypertension or grade 3 of hypertension (SBP=180 mmHg and/or DBP=110mmHg). • LDL-c level equal or higher than 4.9 mmol/L (189,5 mg/dL) • Diabetes with target organ damage (e. g. proteinuria). • Previous CV event (e.g. MI, transient ischemic attack, stroke…). • History of adverse reactions or hypersensitivity associated with the use of active substances, any other angiotensin II receptor blocker, any other statin or any components of the investigational medicinal products used in the trial. • Concomitant treatment with: - antihypertensive drugs used for other indication than AH (e.g. tachyarrhythmia, glaucoma) less than 3 months before the study or in changed dosages less than 3 months before the study - drugs that may produce an increase in BP: systemic corticosteroids, hormonal medications (chronically used oral contraceptives are allowed), adrenergic receptor agonists, cyclosporine, erythropoietin, migraine medications such as triptans. - other lipid-lowering drugs (besides those allowed in protocol): statins, fibrates, nicotinic acid, bile acid exchangers, probucol, ezetimibe. - drugs that may increase the incidence of myositis, myopathy and rhabdomyolyisis if used with HMG-CoA reductase inhibitors (as rosuvastatin) fibric acid derivates including gemfibrozil, cyclosporine, nicotinic acid, azole antifungals, protease inhibitors and macrolide antibiotic, systemic formulation of fusidic acid or within 7 days of stopping fusidic acid treatment. -drugs which increase systemic exposure to rosuvastatin: various protease inhibitors (for ex. atazanavir, lopinavir, tipranavir) in combination with ritonavir. -lithium -acetylsalicylic acid in a dose more than 3 g per day -heparin • Patients to whom ß-blocker therapy cannot be discountinued in one day. • Renal dysfunction (creatinine clearance 5xULN). • Interstitial lung disease. • History of angioedema (hereditary, idiopathic or related to previous treatment). • Hypertensive encephalopathy. • Normal average 24-hour SBP AND DBP obtained by 24h ABPM (<130/80 mmHg at baseline) (if patient’s 24h BP is over 130/80 mmHg, but patient’s office BP below 140/90 mmHg, patient is not included
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective is to assess response rate defined as dual target achievement after 12 weeks of treatment with FDC of rosuvastatin/valsartan: o in patients with mild to moderate essential AH AND primary hypercholesterolemia or mixed dyslipidaemia (type IIb) (LDL-c < 4.9 mmol/L or < 189.5 mg/dL) with moderate*, high* or very** high risk for CV event with additional special focus on effects on arterial properties, 24-h BP variability and BP and LDL-c visit-to-visit variability. * CV risk calculated according to ESC guidelines on CV disease prevention in clinical practice. ** Among very high risk only patients with diabetes mellitus without target organ damage can be included. ;Secondary Objective: Not applicable; Primary end point(s): To assess response rate defined as dual target achievement* after 12 weeks of treatment with Ravalsyo®. *proportion of patients achieving normal office BP and normal LDL-c levels at the same time ;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To assess response rate defined as dual target achievement* after 4 and 8 weeks of treatment with Ravalsyo®. • To assess mean change from baseline in SBP, DBP and LDL-c after 4, 8 and 12 weeks of treatment with Ravalsyo®. • To assess proportions of patients treated with one or both RMs at the end of trial. • To assess response rate defined as dual target achievement* among patients, treated with Ravalsyo® and with one or both RMs at the end of trial. • To assess proportion of compliant patients at each control visit. • To assess visit-to-visit variability of BP and LDL-c [Time Frame: baseline, week 4, week 8, week 12]. • To assess proportion of patients reaching a reduction of central (systolic) BP (in 24-hour measurement) below 120 mmHg [Time Frame: baseline, week 12]. • To assess proportion of patients reaching a reduction of PWV (in 24-hour measurement) for at least 0.5 m/s [Time Frame: baseline, week 12]. • To assess reduction of central pulse pressure [Time Frame: baseline, week 12]. • To assess reduction of total vascular resistance [Time Frame: baseline, week 12]. • To assess proportion of patients reaching a reduction of SBP and DBP variability expressed as reduction of day-night standard deviation (SDdn) by at least 0.5 and that of average real variability by at least 0.5. • To assess response rate after 12 weeks in average 24-hour SBP and DBP, average awake time SBP and DBP, and average sleep time SBP and DBP, all obtained by 24h ABPM: proportion of patients reaching normal average 24h ABPM SBP and DBP (<130/80), normal average awake time SBP and DBP (<135/85) and normal average sleep time SBP and DBP (<120/70). Subgroup 1: patients with baseline mild** HT | — |
Countries
Hungary, Poland, Russian Federation, Serbia
Contacts
Public ContactClinical Trial Coordinator
KRKA Magyarország Kereskedelmi Kft.
Outcome results
None listed