Efficacy and safety of a medicine containing the active substance valsartan, or a medicine (fixed-dose combination) containing the two active substances valsartan and hydrochlorothiazide in the treatment of patients with high blood pressure.

Conditions: Patients with mild to moderate arterial hypertension.
MedDRA version: 14.1Level: LLTClassification code 10020775Term: Hypertension arterialSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.1Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2012-005129-57-SI

Lead Sponsor: Krka, d.d., Novo mesto

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

Patients of both genders with mild to moderate essential hypertension (according to European Guidelines for the management of arterial hypertension 2007) with:
I.systolic blood pressure of 140 – 179 mm Hg and
II.diastolic blood pressure of 90 – 109 mm Hg;
Age 18 years or above;
Written informed consent provided by patients or legally acceptable representative.

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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

•Blood pressure values 180/110 mm Hg or higher during washout period (hypertensive crisis);
•Secondary hypertension (due to renovascular hypertension, diseases of endocrine system (pheochromocytoma, primary hyperaldosteronism, Cushing’s syndrome, acromegaly)), malignant hypertension, treatment-resistent hypertension;
•Hipovolemia due to salt-restricted diet, dyalisis, diarrhea or vomiting;
•Hemodynamically significant aortic stenosis or bilateral stenosis of the renal artery or arterial stenosis of a solitary kidney;
•History of angioedema (hereditary, idiopathic or related to previous treatment);
•Hypertensive encephalopathy;
•Angina pectoris or heart failure requiring treatment with a ß-blocker or a calcium antagonist or cardiovascular accident (unstable angina pectoris, myocardial infarction, transitory ischemic attack-stroke or cerebrovascular insult) within former three months;
•Acute liver disease or hepatic dysfunction and other acute diseases (infection, acute exacerbation of chronic diseases, trauma, surgical intervention) within the period of the past three months;
•Renal failure (creatinin clearance < 60 mL/min) or clinically significant pathologic laboratory values of serum creatinine or potassium;
•Diabetes mellitus treated with insulin or uncontrolled diabetes mellitus with fasting blood glucose greater than 11 mmol/L;
•Concomitant treatment that might influence the final therapeutic effect of the tested active substances (see chapter 6.3);
•Pathological clinical states that could affect patient’s compliance, or have any impact on patient’s survival rate (malignant diseases, alcohol abuse, medicine addiction, psychiatric diseases);
•Pregnancy or breast-feeding (in women of childbearing potential a urine pregnancy test will be performed);
•Hypersensitivity to any of the tested medicines;
•Participation in another clinical trial within thirty days prior to enrolment;
•Patients who are not able out of any reason to fulfil the requirements of the Protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to establish the efficacy and safety of Valsacor (valsartan) and Valsacombi (combination of valsartan and hydrochlorothiazide) in wide populations of patients with mild to moderate arterial hypertension. ;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: 4, 8, 12, 16 weeks<br>;Primary end point(s): Primary endpoint is to determine the antihypertensive efficacy of Valsacor (valsartan) and Valsacombi (combination of valsartan and hydrochlorothiazide) in achieving peripheral target blood pressure control in patients with mild to moderate hypertension. <br>To evaluate the effect of treatment on arterial stiffness and aortic augmentation index and to compare the absolute (mean) differences in central blood pressure reduction versus peripheral blood pressure reduction versus baseline values and to compare central versus peripheral pulse wave.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To compare primary endpoints between the monotherapy versus combination therapy. To evaluate and compare the effect of monotherapy and/versus combination therapy on the erectile function in all male participants by a questionnaire asked before and after 16 weeks of treatment in male patients. To evaluate adverse events.;Timepoint(s) of evaluation of this end point: 4, 8, 12, 16 weeks

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