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
Conditions
Interventions
Product Name: Rostafuroxin
Product Code: PST2238
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Rostafuroxin
CAS Number: 156722
Sponsors
CVIE THERAPEUTICS COMPANY LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the 2 highest doses of Rostafuroxin are able to show a statistically significant difference on reduction of office sitting systolic blood pressure in comparison to the group of patients treated with Losartan 50 mg in either the total population of patients carrying at least one of the following genotypes or combination (Genetic Profile 1) or in the subset of patients of this population carrying only at least one of the following combination of genotypes (Profile 2).;Secondary Objective: •To demonstrate that the 2 highest doses of Rostafuroxin are able to show a statistically significant difference on reduction of office sitting systolic blood pressure in comparison to the group of patients treated with Losartan 50 mg in the subgroup of patients showing the Genetic Profile 3; •To demonstrate that the 2 highest doses of Rostafuroxin are able to show a statistically significant difference on office sitting diastolic blood pressure in comparison to Losartan in the general population and/or in the two pre-defined subgroups; •To compare one another the 3 doses of Rostafuroxin and each one versus Losartan; •To determine a dose/responder profile, if any; •To identify the oral doses of Rostafuroxin which lead to statistically significant differences in daytime, night-time and overall 24-hour ambulatory systolic blood pressure and/or diastolic blood pressure, peak effect, trough effect, trough-to-peak ratio and time to peak effect, in comparison with Losartan; Primary end point(s): Change from baseline to Visit 6 in office blood sitting pressure (SBP). Proportions of responders at Visit 6, defined as “Patients having the mean office SBP (mean of last three measurements) or = 10% with respect to the baseline measurement” at Visit 6 (after two months of therapy). ;Timepoint(s) of evaluation of this end point: 9 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline to Visit 6 in office sitting DBP. • Office sitting DBP and office sitting SBP values and changes from baseline at each study visit. • 24 hours SBP and DBP measurements. 24 hours, Day-time and night-time weighted mean value of both SBP and DBP. • All standard safety endpoints (AEs, vital signs, ECG, laboratory data and physical examination). • Office sitting SBP and DBP corrected as per seasonal variation of temperature (confounding factor). ;Timepoint(s) of evaluation of this end point: 9 weeks for OBP and tollerability, 24 hours for ABPM | — |
Countries
Italy, Taiwan
Contacts
Public ContactProf. Bianchi Giuseppe
Ospedale San Raffaele
Outcome results
None listed