Study to evaluate the efficacy and safety of candesartan and amlodipine combination in comparison to the valsartan and amlodipine association in the treatment of arterial hypertension stages 1 and 2

Completed

• Conditions: Hypertension stages 1 or 2; Circulatory System; Secondary hypertension

• Registration Number: ISRCTN37087271
• Lead Sponsor: ibbs Farmacetica Ltda. (Brazil)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

1. Adult patients over 18 year-old from both genders
2. Informed consent form (ICF) signed by the participant
3. Patients diagnosed with hypertension stages 1 or 2, according to the definitions and orientations publicized in the VI Brazilian Arterial Hypertension Guidelines

Exclusion Criteria

1. Fertile women, independently of the use of contraceptive methods
2. Arterial hypertension over or equal to 180 mmHg (systolic) or 110 mmHg (diastolic) or in use of more than two anti-hypertensive drugs at the same time
3. Known hypersensitivity to study medications
4. Non-adherence to the placebo treatment during the run-in period
5. Laboratory exams collected in the screening visit considered clinically significant by the investigator
6. 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
7. Angina pectoris Canadian Cardiovascular Society (CCS) class III or IV
8. Decompensate angina pectoris New York Heart Association (NYHA) class II or IV
9. BMI over 35 kg/m2
10. Moderate or advanced hepatic insufficiency
11. Severe or decompensate kidney insufficiency, characterized by creatinine clearance lower than 30 mL/min/1,73 m2 of corporal surface or dialyses required
12. Ongoing severe conditions, even if controlled by therapy: gastrointestinal, immunological, cardiovascular or cancer
13. Presence or history of significant edema of lower limbs (++/4+ or more)
14. Myocardial infarction, myocardial revascularization or coronary angioplasty in the last 6 months or myocardial revascularization scheduled for the next 6 months
15. Significant or decompensate cardiac valvulopathy
16. Stroke or transient ischemic attack in the last 12 months or carotid revascularization scheduled for the next 6 months
17. Uncontrolled diabetes (HbA1C over 9%)
18. History of angioneurotic oedema
19. Baseline levels of potassium over than 5 mEq/L
20. Any relevant disease that by investigator judgment may interfere in the study objectives or patients? risks
21. Psychiatric disease that prevent the patient to participate in the study or cognitive disturbs (demential syndrome of any origin)

Study & Design

• Study Type: Interventional
• Study Design: Not specified