Study for comparative evaluation of efficacy and safety of nitrendipino (Caltren) versus nifedipino (Adalat retard) in the treatment of mild arteial hypertension.
- Conditions
- Arterial hypertension stage 1.Z01.3
- Registration Number
- RBR-7ynkx6
- Lead Sponsor
- ibbs Farmaceutica Ltda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- other
- Sex
- Not specified
- Target Recruitment
- Not specified
Adult patients over 18 year-old from both genders;
ICF signed by the participant;
Patients diagnosed with hypertension stage 1, according to the definitions and orientations publicized in the VI Brazilian Arterial Hypertension Guidelines.
fertile women, independently of the use of contraceptive methods;
known hypersensitivity to study medications;
non-adherence to the placebo treatment during the run-in period;
laboratory exams collected in the screening visit considered clinically significant by the investigator;
ECG performed during the screening visit showing ventricular arrhythmia, atrium-ventricular block of 2nd or 3rd degree, arrhythmia, tachycardia, bradycardia, or any other alteration considered clinically significant by the investigator;
Angina pectoris CCS class III or IV;
Decompensate angina pectoris NYHA class II or IV;
BMI over 35 kg/m2;
moderate or advanced hepatic insufficiency;
Severe or decompensate kidney insufficiency, characterized by creatinine clearance lower than 30 mL/min/1,73 m2 of corporal surface or dialyses required;
ongoing severe conditions, even if controlled by therapy: gastrointestinal, immunological, cardiovascular or cancer;
presence or history of significant edema of lower limbs (++/4+ or more);
myocardial infarction, myocardial revascularization or coronary angioplasty in the last 6 months or myocardial revascularization scheduled for the next 6 months;
significant or decompensate cardiac valvulopathy;
stroke or transient ischemic attack in the last 12 months or carotid revascularization scheduled for the next 6 months;
Uncontrolled diabetes (HbA1C over 9%);
history of angioneurotic edema;
any relevant disease that by investigator judgment may interfere in the study objectives or patients’ risks;
psychiatric disease that prevent the patient to participate in the study or cognitive disturbs (demential syndrome of any origin).
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference between the two treatment groups with respect to the mean values of <br>SYSTOLIC blood pressure (mmHg), measured by ABPM (ambulatory blood pressure monitoring) during 24 hours before and after treatment.
- Secondary Outcome Measures
Name Time Method Difference between the two treatment groups with respect to the mean values of <br>DIASTOLIC blood pressure (mmHg), measured by ABPM (ambulatory blood pressure monitoring) during 24 hours before and after treatment.