Arterial hypertension MedDRA version: 6.1 Level: PT Classification code 10015488
Conditions
Interventions
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: Barnidipine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical Form: Table
Sponsors
ISTITUTO AUXOLOGICO ITALIANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients of any gender and aged 30-74 years - Patient under treatment with stable anti-hypertensive therapy with losartan 50 mg/day for at least 6 weeks and not adequately controlled as for blood pressure sitting DBP of 90 to 109 mm Hg SBP of 140 to 179 mm Hg confirmed by two consecutive measurements, taken at Visits 1 and 2 - Patients with elevated average ambulatory day-time blood pressure DBP 85 mm Hg SBP 135 mm Hg at Visit 2 - If female and of child-bearing potential, the patient must be non-nursing and practicing an effective method of contraception throughout the study duration. All females of child-bearing potential must have a negative serum or urine pregnancy test prior to start of study medication - Written informed consent. 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: - Secondary hypertension - Unstable angina pectoris, myocardial infarction in the previous 4 weeks, chronic heart failure not under treatment - Clinically important hepatic, renal, hematological, metabolic, neurological, or pulmonary disorder or dysfunction - History of allergy or hypersensitivity or intolerance to barnidipine or to other dihydropyridines - Concomitant treatment with drugs potentially interfering with barnidipine - Any condition which renders the patient unable to complete the study or increases the risk to the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint is the mean difference visit 4 visit 2 of ambulatory day-time DBP between patients treated with the combination of losartan and barnidipine in comparison with patients who continued the therapy with losartan alone.;Main Objective: To evaluate the effect of 10-20 mg/day of barnidipine as add-on therapy in patients not adequately controlled on therapy with angiotensin II receptor antagonist losartan 50 mg/day sitting DBP of 90 to 109 mm Hg SBP of 140 to 179 and day-time DBP 85 mm Hg day-time SBP 135 mm Hg .;Secondary Objective: The study will also assess study drug effects on average ambualtory day-time SBP, average ambulatory 24 hour SBP and DBP, average ambulatory night-time SBP and DBP, office trough SBP and DBP 24 hour after last dose , rate of SBP and DBP responder patients based on office blood pressure, rate of SBP and DBP normalised patients based on office blood pressure, rate of SBP and DBP normalised patients based on average day-time blood pressure, smoothness index, morning surge and trough to peak ratio | — |
Countries
Italy
Outcome results
None listed