mild to moderate hypertension
Conditions
Interventions
Trade Name: Lorista
Product Name: LORISTA
Pharmaceutical Form: Tablet
INN or Proposed INN: losartan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name:
Sponsors
KRKA, d. d., Novo mesto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients aged from 20 to 80 years; 2.Patients with mild to moderate essential hypertension (according to European (ESH-ESC) Guidelines for the management of arterial hypertension 2003) with: •diastolic blood pressure of 90 – 109 mm Hg and •systolic blood pressure of 140 – 179 mm Hg; 3.Newly discovered and previously untreated patients or patients with hypertension unsuccessfully treated with monotherapy or combination of antihypertensive drugs (fixed dose or non-fixed dose combinations) or patients in whom antihypertensive therapy needs to be changed due to adverse reactions experienced with previous antihypertensive therapy. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •patients with secondary hypertension due to diseases of endocrine system (pheochromocytoma, primary hyperaldosteronism, Cushing’s syndrome, acromegaly) •patients with renovascular hypertension •patients with coarctation of aorta or significant aortic stenosis •patients with malignant hypertension •patients with hypertensive encephalopathy •patients hypersensitive to any of the tested drugs •pregnant women and nursing mothers •patients with a history of myocardial infarction, stroke or transient ischemic attack in the last 3 months •patients with angina pectoris requiring treatment with a ß-blocker or a calcium antagonist •patients with heart failure or known left ventricular ejection fraction three times above the normal levels) •patients with a condition that, in the treating physician’s opinion, requires treatment with a drug or combination of drugs that might affect the final therapeutic effect of losartan and hydrochlorothiazide •patients with acute disease (infection, acute exacerbation of chronic diseases, trauma, surgical intervention) within the period of the past two months •patients unwilling or unable to participate (psychiatric disorders, alcohol or drug abuse, …).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this trial is to confirm the antihypertensive effect of Lorista tablets (50 mg of losartan) and Lorista-H tablets (fixed dose combination of 50 mg of losartan and 12,5 mg of hydrochlorothiazide) in patients with mild to moderate hypertension: •previously untreated or •those with hypertension unsuccessfully treated with monotherapy or combination of antihypertensive drugs (fixed dose or non-fixed dose combinations) or •in whom antihypertensive therapy needs to be changed due to adverse reactions experienced with previous antihypertensive therapy, and to establish the tolerance and the effect of therapy on the patient’s quality of life. ;Secondary Objective: ;Primary end point(s): reduction of blood pressure below 14090 mmHg | — |
Countries
Czech Republic
Outcome results
None listed