Ensaios Clínicos (somente visualização)

Listagem completa dos ensaios clĂ­nicos importados do XML ICTRP.

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162
RBR-7ynkx6
Study for comparative evaluation of efficacy and safety of nitrendipino (Caltren) versus nifedipino (Adalat retard) in the treatment of mild arteial hypertension.
Open label, prospective, parallel, multicenter and randomized study for comparative evaluation of efficacy and safety of nitrendipino (Caltren) versus nifedipino (Adalat retard) in the treatment of arteial hypertension stage 1.
None
other
Intervention
3, randomized-controlled, open
3
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None
None
2012-02-13
2012-06-01
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Libbs Farmaceutica Ltda
Libbs Farmaceutica Ltda
https://ensaiosclinicos.gov.br/rg/RBR-7ynkx6
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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).
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2026-06-01 05:16:29