Study for comparative evaluation of efficacy and safety of nitrendipino (Caltren) versus nifedipino (Adalat retard) in the treatment of mild arteial hypertension.

• Register: REBEC
• Last refreshed on: 27 May 2013
• Main ID: RBR-7ynkx6
• Date of registration: 13/02/2012
• Primary sponsor: Libbs Farmaceutica Ltda - Sao Paulo, SP, Brazil
• Public title: Study for comparative evaluation of efficacy and safety of nitrendipino (Caltren) versus nifedipino (Adalat retard) in the treatment of mild arteial hypertension.
• Scientific title: 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.
• Date of first enrolment: 01/06/2012
• Target sample size: 190
• Recruitment status: other
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-7ynkx6/
• Study type: Intervention
• Study design: Clinical study, parallel, two-arms, open-label, randomized, phase 3.

Countries of recruitment

Brazil

Contacts

• Name: Debora Rodrigues
• Affiliation: Libbs Farmaceutica Ltda

• Name: Jairo Borges
• Affiliation: Libbs Farmaceutica Ltda

Key inclusion & exclusion criteria

Inclusion criteria: 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.

Exclusion criteria: 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).

Age minimum: 40Y
Age maximum: 40Y
Gender: -

Health Condition(s) or Problem(s) studied

Arterial hypertension stage 1.
Z01.3

I00-I99

Intervention(s)

It is foreseen the screening of 190 patients. Screen failures at 10% and discontinuation of 25% are expected.
At the initial visit, patients will be evaluated regarding the inclusion and exclusion criteria and submitted to laboratory exams and EKGs. After this week, patients who were not excluded by laboratory results will receive open-label placebo for two more weeks. Next, study treatment will be initiated after randomization (1:1) to one of the treatment arms: Nitrendipine (10 mg) or Nifedipine (10 mg), both administered twice a day by mouth. After one month treatment, patients who did not control blood pressure will have dose medication uptitrated to 20 mg.
Before and after the medication treatment (8 weeks interval), patients will be submitted to 24h ABPM exam. At final visit, laboratory exams and EKG will be performed again.

Primary Outcome(s)

Difference between the two treatment groups with respect to the mean values of
SYSTOLIC blood pressure (mmHg), measured by ABPM (ambulatory blood pressure monitoring) during 24 hours before and after treatment.

Secondary Outcome(s)

Difference between the two treatment groups with respect to the mean values of
DIASTOLIC blood pressure (mmHg), measured by ABPM (ambulatory blood pressure monitoring) during 24 hours before and after treatment.

Secondary ID(s)

3122-CEP/HUPE–CAAE: 0262.1.228.000-11

Source(s) of Monetary Support

Libbs Farmaceutica Ltda - Sao Paulo, SP, Brazil

Secondary Sponsor(s)

Libbs Farmaceutica Ltda - Sao Paulo, SP, Brazil