Effetto antipertensivo di differenti dosi del Rostafuroxin in confronto con Losartan, valutato con Rilevazioni Pressorie Ambulatoriali e Monitoraggio Pressorio nelle 24 ore in pazienti ipertesi portatori di uno specifico profilo genetico.

Phase 1

• Conditions: Patients with arterial hypertension, bearers of a specific genetic profile (Presence of at least one mutated genotype or combination of genotypes corresponding to the list provided in Genetic Profile 1).; MedDRA version: 20.0 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-022073-34-IT
• Lead Sponsor: CVIE THERAPEUTICS COMPANY LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 280

Inclusion Criteria

The main criteria to be included in the study is to be a patient with arterial hypertension, bearers of a specific genetic profile (Genetic Profile 1). Patients have to be aged between 25 and 60 years, have already undertaken lifestyle recommendations and still having an abnormal systolic and diastolic blood pressure levels. They must not have been previously treated with any specific antihypertensive drug and they must not assume drugs like diuretics, ?-blocker agents, Ca-antagonist, ACE inhibitors and AT1-receptor blockers, for other reasons. They must not be on statines treatment or to be Diabetic (fasting plasma glucose > 125 mg/dl). Their value of the sitting systolic blood pressure (SBP) must range between 140 and 169 mmHg and the sitting diastolic blood pressure (DBP) must range between 85 and 100 mmHg, after an adequate period of lifestyle changes. They do not have to present known causes of secondary hypertension, cardiac disease requiring prohibited pharmacological treatment or history of renal artery disease or a myocardial infarction occurred within the last 6 months.
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 280
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Known causes of secondary hypertension; •Severe or malignant hypertension; •History of renal artery disease; •Significant renal (estimated creatinine clearance = 50 mL/min) or hepatic disease (SGOT and/or SGPT greater than 2 times the upper limit of the normal range); •Cardiac disease requiring prohibited pharmacological treatment or history of myocardial infarction within the last 6 months; •Atrial Fibrillation.

Study & Design

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